Catalog Number THP3036X150-G |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Ischemia (1942); Thrombosis/Thrombus (4440)
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Event Date 02/02/2024 |
Event Type
Death
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Manufacturer Narrative
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Manufactures narrative clinical code: 4440 - thrombosis / thrombus: event was reported as thrombosis of the msa visceral artery with mesenteric ischemy.Impact code: 1802 - death: patient death was 2 day after implant.Medical device code: 3190 - insufficient information: a/w additional information from site in regards to this event.Component code: 4755 - part/component/ sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a five year review of similar complaints (thoraflex hybrid jan 19 - jan 24 vs artery occlusion/ thrombosis) gave an occurrence rate of (b)(4) (complaints vs sales).4114 - device not returned: device remains implanted.3331 - analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4111 - communication/interview: additional information received from site on 14 feb 24; the patient develops mesenteric ischemia due to thrombosis of the sma which will lead to non-viable ischemia of the colon and necrosis of the small intestine without possible recovery.
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Event Description
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As reported: j+2 thrombosis of the msa visceral artery with mesenteric ischemy.Patient death j+2.
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Manufacturer Narrative
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Manufactures narrative: clinical code: 4440 - thrombosis / thrombus: event was updated by the site on 13 mar 24 post procedure thrombosis of the (coeliac trunk) and sma (superior mesenteric artery) visceral arteries 1942 - ischemia: the patient develops mesenteric ischemia due to thrombosis of the sma which will lead to non-viable ischemia of the colon and necrosis of the small intestine without possible recovery.Impact code: 1802 - death: patient death was 2 day after implant.Medical device code: 2993 - adverse event without identified device or use problem: full batch review was performed which showed no issues from raw material to finished product during manufacturing process of this device.Component code: 4755 - part/component/ sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a five year review of similar complaints (thoraflex hybrid jan 19 - jan 24 vs artery occlusion/ thrombosis) gave an occurrence rate of (b)(4) (complaints vs sales).4117 - device not accessible for testing: device remains implanted.3331 - analysis of production records: full batch review was performed which showed no issues from raw material to finished product during manufacturing process of this device.4111 - communication/interview: additional information received from site on 14 feb 2024; the patient develops mesenteric ischemia due to thrombosis of the sma which will lead to non-viable ischemia of the colon and necrosis of the small intestine without possible recovery.The patient had no prior history of blood clotting and no calcification of the artery.Patient also did not has any allergies to the graft components.Investigation findings: 213 - no device problem found: full batch review was performed which showed no issues from raw material to finished product during manufacturing process of this device.No causal link between the event and device deficiency could be established.Investigation conclusion: 67 - no problem detected: full batch review was performed which showed no issues from raw material to finished product during manufacturing process of this device.No causal link between the event and device deficiency could be established.
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Event Description
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Initially reported as: j+2 thrombosis of the msa visceral artery with mesenteric ischemy.Patient death j+2.Event was updated by the site on 13 mar 2024 post procedure thrombosis of the (coeliac trunk) and sma (superior mesenteric artery) visceral arteries patient death j+2.This report is being submitted as follow up #1 for mfg for manufacturing report # 9612515-2024-00011 to provide event closure information for comp (b)(4).
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Search Alerts/Recalls
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