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

Model Number GELWEAVE EXTRA LONG BIFURCATE

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/27/2019

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 294659989
• Report Number: 9612515-2022-00003
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881107646
• UDI-Public: 05037881107646
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• 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): Required Intervention
• Patient Sex: Female