MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE EXTRA LONG BIFURCATE

Model Number	GELWEAVE EXTRA LONG BIFURCATE
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to vascutek via the panther study programme as follows: reported right leg thrombosis with thrombus within the right deep femoral artery, left deep femoral artery and the left hypogastric artery.The graft was implanted on (b)(6) 2019.The patient had a haemorrhagic shock event several hours after the bypass procedure ae first detected on (b)(6) 2019 thrombectomy was performed on (b)(6) 2019, ae resolved on (b)(6) 2019.This event was indicated as device related, not procedure related, patient pre-existing condition unknown).No device defect or deficiency was reported by the site.
Additional Manufacturer Narrative
Manufacturers narrative: (b)(4).Type of investigation: historical data analysis: a five-year review of similar reported thrombosis/occlusive events relating to gelweave branded grafts was completed, an occurence rate of (b)(4) (complaints v sales) was confirmed and no negative trend was detected.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.Communication/interviews further information on event and its circumstances has been requested from the reporting site as well as clarification of the event/ device relationship.Information provided has suggested that a blood transfusion shortly after implant may have been a factor; as well as how the patient was positioned during the procedure.Device not accessible for testing.The actual device involved in the adverse event will not be returned as it remains insitu within the patients anatomy.Investigation findings: no device problem found.No issue has been found upon review of the retained device history records for this device/batch.Investigation conclusions: as the device was not available for evaluation, review of the retained manufacturing records confirmed that the device was manufactured to specifications and the statements from the site regarding the procedure; no root cause can be determined for the cause of this issue.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE EXTRA LONG 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: 14304356
• Report Number: 9612515-2022-00003
• Device Sequence Number: 5026521
• Product Code: DSY
• UDI-Device Identifier: 05037881107646
• UDI-Public: 05037881107646
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: GELWEAVE EXTRA LONG BIFURCATE
• Device Catalogue Number: 731809XL55
• Device Lot Number: 17065723
• 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: 04/22/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• 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 Sex: Female