MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE BIFURCATE

Model Number	GELWEAVE BIFURCATE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The site advised that the device is not available as it was discarded; therefore no evaluation of the graft was possible.(b)(4).Type of investigation - review of similar complaints of leakage for all gelweave branded devices gave an occurrence rate of (b)(4).Type of investigation - information has been requested on multiple occasions from the clinician regarding the procedure and how the graft was used.If additional information is supplied by the reporting site; a follow up report will be generated documenting any updates in the investigation.Type of investigation - a review of the retained qc and manufacturing records for this batch (with attention to all in process and base material porosity testing) confirmed that the batch was manufactured to its design specification.Type of investigation - the site advised that the device is not available.Investigation findings - no issue was found with the manufacturing of the batch (based on the review of the retained production records).Investigation conclusions - the root cause of the reported defect could not be determined.Vascutek ltd.Considers this event as closed.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process, if an adverse trend develops action may be taken at that time.
Event or Problem Description
On (b)(6) 2021 a gelweave bifurcate graft appeared to leak during a leak test (completed on site at the hospital) allegedly after being implanted and then extracted from the body.The event was reported as device related.Device is not available as it was discarded.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11884304
• Report Number: 9612515-2021-00016
• Device Sequence Number: 1363286
• Product Code: DSY
• UDI-Device Identifier: 05037881105819
• UDI-Public: 05037881105819
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K964665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: GELWEAVE BIFURCATE
• Device Catalogue Number: 731608-G
• Device Lot Number: 21540851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention