MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE BIFURCATE

Model Number	GELWEAVE BIFURCATE
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to vascutek via the panther study programme as follows: on (b)(6) 2018 a gelweave bifurcate graft was implanted.The following day (b)(6) 2019) post-operative acute occlusion of the left side of aortofemoral prosthesis occurred.The patient underwent a thrombectomy procedure and an adjustment to medication which appeared to resolve the issue without further complication.The site has indicated that this event is related to the procedure, but also possibly related to the device and patient pre-existing conditions.
Additional Manufacturer Narrative
(b)(4).Type of investigation: historical data analysis - a similar event review was performed for reported occlusion/thrombosis with gelweave branded devices between jan 17 and jun 22.A similar event rate of (b)(4) was confirmed.Trend analysis - no negative trend was identified.Communication/interviews - further information has been requested.Device not accessible for testing - the graft remains insitu.Analysis if production records - qc, manufacturing and physical test records of the base material were retrieved and reviewed and show that the batch was manufactured to design specification and all tests met acceptance criteria.Investigation findings: no device problem found - no issue has been found upon review of the retained device history records for this device/batch.Results pending completion of the investigation.Investigation conclusions: conclusion is not yet available as critical information has been requested from the site as well as the current status of the device.
Additional Manufacturer Narrative
Manufacturers narrative section h6 investigation findings: code 213 - no device problem found - no issue has been found upon review of the retained device history records for this device/batch.Investigation conclusions: code 22 - known inherent risk of device - arterial or venous thrombosis are known and expected occurrences and is listed within current ifu's as a potential adverse event.Code 4315 - cause not established - the patient has significant co-morbidities that could have caused or contributed to this occurrence.Vascutek ltd requested clarification as to why this event was indicated as possibly device related, when no device deficiencies have been reported and also that all pre op/post op ct / xray imaging be provided to aid the investigation.Despite multiple requests, no additional information has been provided.Therefore no root cause can be definitively determined in this case.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
Event or Problem Description
This event was reported to vascutek via the panther study programme as follows: on (b)(6) 2021 a gelweave bifurcate graft was implanted.The following day ( (b)(6) 2021) post-operative acute occlusion of the left side of aortofemoral prosthesis occurred.The patient underwent a thrombectomy procedure and an adjustment to medication which appeared to resolve the issue without further complication.The site has indicated that this event is related to the procedure, but also possibly related to the device and patient pre-existing conditions.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 14773655
• Report Number: 9612515-2022-00008
• Device Sequence Number: 13790001
• Product Code: DSY
• UDI-Device Identifier: 05037881105833
• UDI-Public: 05037881105833
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 01/31/2024
• Device Model Number: GELWEAVE BIFURCATE
• Device Catalogue Number: 732010-G
• Device Lot Number: 21653483
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 67 KG