MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID

Catalog Number THP3036X150B-G

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/02/2024

Event Type  Death  

Manufacturer Narrative

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.

Event Description

As reported: j+2 thrombosis of the msa visceral artery with mesenteric ischemy.Patient death j+2.

Manufacturer Narrative

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 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.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.

Event Description

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 24 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).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow,, renfrewshire PA4 9 RR,; UK PA4 9RR,
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow,, renfrewshire PA4 9 RR,; UK PA4 9RR,
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18795927
• MDR Text Key: 336394405
• Report Number: 9612515-2024-00011
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP3036X150B-G
• Device Lot Number: 25215178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Male