{
  "docId": "019dd923-622c-750b-8b9a-40e2965928db",
  "docSlug": "e5bffbaac707",
  "documentTitle": "TransMedics (TMDX)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Scorpion Capital",
  "documentKindSlug": "research-note",
  "documentKindLabel": "Research note",
  "sourceTypeSlug": "short_seller",
  "sourceTypeLabel": "Short seller",
  "presentationDate": "2025-01-10 00:00:00",
  "orientation": "landscape",
  "aspectRatio": 1.3333334,
  "pageNumber": 341,
  "pageCount": 342,
  "prevPage": 340,
  "nextPage": 342,
  "slideType": "quote_slide",
  "function": "expose_contradiction",
  "density": "dense",
  "nDataPoints": 0,
  "notes": "The slide highlights a critical failure in safety protocols and regulatory compliance as perceived by an industry expert.",
  "elementsJson": [
    "paragraph",
    "quote_block",
    "footnote"
  ],
  "metadataConfidence": 1,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-40e2965928db/341",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db#slide-341",
  "components": [
    {
      "bbox": null,
      "kind": "callout",
      "text": "When there are certain never events...under the watch of TransMedics...I’ve been struggling to find anyone who takes ownership of it...to the point where I have to request them to show proof that they self-report to the FDA.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-5374-767b-b3c0-4607d43fb57a",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.35,
        "w": 0.86,
        "x": 0.07,
        "y": 0.07
      },
      "kind": "paragraph",
      "text": "The MGH executive indicated that there are not minor malfunctions but “adverse events that should never occur,” calling them “Never Events” in the “highly, highly regulated world of transplants” – such as a failure that could “put the organ at risk or when a recipient will be put under anesthesia waiting for the organ and a device malfunction occurs, and you lose the organ...” He indicated “certain never events” with TransMedics that required that he “be called within a few hours by our governing body and regulatory body, so would my chief compliance officer...either it’s a sentinel event or adverse event”; “when there are certain never events...under the watch of TransMedics...I’ve been struggling to find anyone who takes ownership of it...to the point where I have to request them to show proof that they self-report to the FDA.”",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "64b75982-7c57-463b-9155-46798afc1f03",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.45,
        "w": 0.86,
        "x": 0.07,
        "y": 0.48
      },
      "kind": "quote",
      "text": "Never events like losing organs due to device failure or human error; failing to report; called by regulatory bodies\n“Device failure-wise, it just goes along with what I had mentioned before, how any time that there’s even a device failure, any time they could potentially even put the organ at risk or when a recipient will be put under anesthesia waiting for the organ and a device malfunction occurs, and you lose the organ? That’s a never event [...] these are adverse events that should never occur, and, obviously, you’d want to have many different countermeasures, many different plan Bs and Cs that would back things up so that you would never, number one, lose the organ; two, have a situation where either the organ is not procured because of human error or such, or there are delays that were not mitigated. And so, there are certain never events that have occurred where in the highly, highly regulated world of transplants, I would essentially be called within a few hours by our governing body and regulatory body, so would my chief compliance officer, and we’d be on a phone call directly addressing the issue, either it’s a sentinel event or an adverse event and there would be clear processes related to reporting of the event, either self-reporting to the DPH, CMS, OPTN, or UNOS and PFC. And that would happen roughly within 24 hours. When there are certain never events that have occurred under the watch of TransMedics...I’ve been struggling to find anyone who takes ownership of it, anyone who either have self-reports to the FDA or not, and to the point where I have to request them to show proof that they self-report to the FDA.” – Veteran transplant administrator at Massachusetts General Hospital",
      "attrs": null,
      "subkind": "testimonial",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "5216e126-79f4-4788-ab13-d214569bc1ae",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "quote",
      "text": "“Device failure-wise, it just goes along with what I had mentioned before, how any time that there’s even a device failure, any time they could potentially even put the organ at risk or when a recipient will be put under anesthesia waiting for the organ and a device malfunction occurs, and you lose the organ? That’s a never event [...] these are adverse events that should never occur, and, obviously, you’d want to have many different countermeasures, many different plan Bs and Cs that would back things up so that you would never, number one, lose the organ; two, have a situation where either the organ is not procured because of human error or such, or there are delays that were not mitigated. And so, there are certain never events that have occurred where in the highly, highly regulated world of transplants, I would essentially be called within a few hours by our governing body and regulatory body, so would my chief compliance officer, and we’d be on a phone call directly addressing the issue, either it’s a sentinel event or an adverse event and there would be clear processes related to reporting of the event, either self-reporting to the DPH, CMS, OPTN, or UNOS and PFC. And that would happen roughly within 24 hours. When there are certain never events that have occurred under the watch of TransMedics...I’ve been struggling to find anyone who takes ownership of it, anyone who either self-reports to the FDA or not, and to the point where I have to request them to show proof that they self-report to the FDA.” — Veteran transplant administrator at Massachusetts General Hospital",
      "attrs": null,
      "subkind": null,
      "toolName": "Authority citation",
      "toolSlug": "authority-citation",
      "confidence": null,
      "componentId": "019dd953-5374-767b-b3c0-483a41ad13d2",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.3,
        "x": 0.07,
        "y": 0.95
      },
      "kind": "source-note",
      "text": "Source: Scorpion Capital consultation calls with experts",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "a0ea0d12-e2ab-432e-833b-a8d5d84ea33f",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [],
  "arcBeats": [],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}