MAUDE Adverse Event Report: VASCUTEK LTD Gelweave¿; GELWEAVE BIFURCATE

Model Number	731608XL55
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
His event was reported to vascutek ltd via the panther study programme as follows: on (b)(6) 2021 a gelweave bifurcate graft was implanted to treat aorto-femoral aneurysm.Shortly after procedure post-operative acute ischemia due to early occlusion of gelweave device identified.To resolve the event medication (unknown type) was given to the patient.Thrombus was removed from the device.12x38mm bentley stent was implanted in adrenal aorta above gelweave graft to avoid stenosis of anastomotic site.Patient recovered without sequelae.The site has indicated that this event is possibly related to the procedure, device and patient pre-existing conditions.
Additional Manufacturer Narrative
Manufacturers narrative section h6 health effect - clinical code: 4580 - insufficient information - gelweave bifurcate graft was implanted to treat aorto-femoral aneurysm.Shortly after procedure post-operative acute ischemia due to early occlusion of gelweave device identified.Health impact - impact code: 4625 - additional surgery- to resolve the event medication (unknown type) was given to the patient.Thrombus was removed from the device.12x38mm bentley stent was implanted in adrenal aorta above gelweave graft to avoid stenosis of anastomotic site.Medical device problem code: 2423 - obstruction of flow - thrombus was removed from the device.12x38mm bentley stent was implanted in adrenal aorta above gelweave graft to avoid stenosis of anastomotic site.Component code: 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or subassemblies.Type of investigation: 4110 - trend analysis.A similar event review was performed for occlusions in gelweave grafts between jan 19 and jun 23.A similar event rate of 0.006% was confirmed.No negative trend in the number of events was identified.4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications.Investigation findings: 213 - no device problem found - no issue has been found upon review of the retained device history records.Complainant aslo confirmed that the device was not kinked or twisted, also the patient did not have any allergies to the grafts components.Investigation conclusion: 4315 - cause not established- device showed occlusion approximately 3 hours after procedure.A thrombectomy was carried out and the graft remained patent afterwards.Patient recovered, event resolved without sequelae.

• Brand Name: Gelweave¿
• Common Device Name: GELWEAVE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 17223645
• Report Number: 9612515-2023-00006
• Device Sequence Number: 7076099
• Product Code: DSY
• UDI-Device Identifier: 05037881107639
• UDI-Public: 05037881107639
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 731608XL55
• Device Catalogue Number: 731608XL55
• Device Lot Number: 21540854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male