{ "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": 342, "pageCount": 342, "prevPage": 341, "nextPage": null, "slideType": "quote_slide", "function": "expose_contradiction", "density": "dense", "nDataPoints": 0, "notes": "The slide uses highlighted text to emphasize key allegations of non-reporting and unethical behavior.", "elementsJson": [ "paragraph", "quote_block", "footnote" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-40e2965928db/342", "deckHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db#slide-342", "components": [ { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "callout", "text": "Failing to report device malfunction issues known among transplant centers", "attrs": null, "subkind": "primary", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "77467dbc-3621-4d78-a307-067e19b3ef13", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.61 }, "kind": "callout", "text": "MGH uncomfortable with lack of FDA reporting for device malfunctions", "attrs": null, "subkind": "primary", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "eb4899af-4bac-4765-83f8-9141b5c59db6", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "callout", "text": "I wouldn’t be surprised if it has happened to us or around certain cases that we’ve been involved with.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-5374-767b-b3bf-bdf4167da52f", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.65 }, "kind": "paragraph", "text": "Q: “It sounds like they’re actively trying to conceal these times when a surgeon messed up, or the device malfunctioned. Have you seen a pattern of concealment or where they’re actually faking or misreporting it? People are telling me that and I’m wondering what you’ve observed directly or heard about.”\nA: “...that one individual feeling pressured or bullied to either redact the report and adjust the content of that, that is, I mean, unethical is not even what I would call it, but I would just call it that for now...what’s sad to say out loud is I wouldn’t be surprised if it has happened to us or around certain cases that we’ve been involved with. As I mentioned before, their response related to self-reporting to the FDA related to the device malfunction didn’t fall within their margin of error; that didn’t seem right to me, and we had to go through some other routes to get that resolved or at least looked at. As I mentioned, when we started this way back when, and it was still awaiting the FDA, we were working with them very hand-in-hand because it did seem like it was a very promising technology. There was a fundamental alignment of our philosophies of what we wanted to do together. That is not the case anymore.” – Veteran transplant administrator at Massachusetts General Hospital", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d3919bf6-d512-4945-ad96-247e6bfe75bd", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.43 }, "kind": "quote", "text": "“There have been situations where they have even stated that they have not needed to report it based on the volume that they have, which to me doesn’t make any sense because these are never events. These are situations where patients are not able to get a life-saving heart because of an issue. And, on top of that, because the transplant world is small, we all talk to each other. We all know what’s going on. And the fact that we know of three or four situations where that’s occurred with other transplant programs, and TransMedics has not even self-reported that. I mean, any type of recall...TransMedics has not done that and I’m a bit taken aback.” – Veteran transplant administrator at Massachusetts General Hospital", "attrs": null, "subkind": "testimonial", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "c3ac2348-c40d-4ecc-af30-703feab14acc", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "“There have been situations where they have even stated that they have not needed to report it based on the volume that they have, which to me doesn’t make any sense because these are never events. These are situations where patients are not able to get a life-saving heart because of an issue. And, on top of that, because the transplant world is small, we all talk to each other. We all know what’s going on. And the fact that we know of three or four situations where that’s occurred with other transplant programs, and TransMedics has not even self-reported that. I mean, any type of recall...TransMedics has not done that and I’m a bit taken aback.” — Veteran transplant administrator at Massachusetts General Hospital", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-5374-767b-b3bf-c3e540f62cd5", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "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": "ee9e2251-9b9d-42da-8c70-c266e6e4ab24", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "The MGH executive stated “these are situations where patients are not able to get a life-saving heart because of an issue....because the transplant world is small, we all talk to each other...the fact that we know of three or four situations where that’s occurred with other transplant programs, and TransMedics has not even self-reported that...I mean, any type of recall...TransMedics has not done that and I’m a bit taken aback...their response related to the device malfunction....that didn’t seem right to me...when we started this way back when, and it was still awaiting the FDA, we were working with them hand-in-hand...there was a fundamental alignment...that is not the case anymore.”", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "5f978c5f-f513-48d8-a64f-1d36c7f941ba", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }