{ "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": 327, "pageCount": 342, "prevPage": 326, "nextPage": 328, "slideType": "expose_contradiction", "function": "expose_contradiction", "density": "dense", "nDataPoints": 1, "notes": "The slide uses direct quotes from former employees to build a case for corporate malfeasance and product failure.", "elementsJson": [ "paragraph", "quote_block" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-40e2965928db/327", "deckHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db#slide-327", "components": [ { "bbox": null, "kind": "callout", "text": "when it came to reporting, everything was done to basically not report as much as possible.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-5374-767b-b3bd-e52230488270", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.23, "w": 0.86, "x": 0.07, "y": 0.72 }, "kind": "list", "text": "Allegedly trying to “not report” safety incidents “as much as possible”\nQ: “There are not many cases reported in MAUDE. Is the company just not reporting them to the FDA?”\nA: “I think there’s a certain number of events that go unreported. Their system is lacking a lot historically in terms of reporting.”\nQ: “Did you ever try to report something and you were told by the CEO or the VP that it doesn’t need to be reported? Were they trying to underreport?”\nA: “Yeah, that was definitely the case...when some malfunction was recognized, everyone was blamed but the device, so the users, the support staff, the engineers and such and such. There was a lot of finger-pointing and blaming...upper management was taking every failure very, very personally. The investigation was very thorough for every case of malfunction. That much I can tell you because I participated in those investigations heavily. But when it came to reporting, everything was done to basically not report as much as possible.” - Former employee in medical safety and clinical affairs", "attrs": null, "subkind": "bullet", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "1be8c99a-1d4a-49b5-ba7f-5ef07289af73", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "list", "text": "Significant percentage of organs allegedly lost to device failure\n“It was a pretty complex device, so many malfunctions....there were some kinks so the fluids and the gas were not able to flow properly. Some faulty filters...I think it’s between 5-7% of the time, they lose the organ because of a failure.” - Former employee in medical safety and clinical affairs", "attrs": null, "subkind": "bullet", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "7799eff2-a74a-4aca-9f43-baa94c655595", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Ex-employees, surgeons, and OPO’s indicate that TransMedics OCS devices are plagued by failures leading to the loss of a significant percentage of organs; that livers in particular are prone to becoming necrotic, essentially rotting on the device, with dead tissue and parts of livers falling off; that the issues are prevalent enough that customers question why there hasn’t been an FDA recall; and that TransMedics is allegedly engaged in a systematic cover-up by lying to physicians, failing to report device failures to the FDA as required, with the CEO allegedly pressuring employees to doctor safety reports. We begin with an ex-employee in medical safety roles, who stated that “it was a pretty complex device, so many malfunctions...kinks so the fluids and the gas were not able to flow properly...between 5-7% of the time, they lose the organ because of a failure.” The employee indicated a cover-up: “yeah, that was definitely the case...I participated in those investigations heavily...when it came to reporting, everything was done to basically not report as much as possible.”", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "b465e78e-aad0-477f-97c4-67a47d78f7d7", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "“it was a pretty complex device, so many malfunctions...kinks so the fluids and the gas were not able to flow properly...between 5-7% of the time, they lose the organ because of a failure.” — Former employee in medical safety and clinical affairs", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-5374-767b-b3bd-eb7753fd8a0c", "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": "76412113-d2ba-4a43-b452-46454577b2a7", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [ { "name": "fraud-exposure", "slug": null, "matchId": "b0f02f9c-1216-43bb-af84-e8e114a38bab", "evidence": "The slide systematically presents allegations of regulatory non-compliance and cover-ups.", "confidence": 0.9 } ], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }