MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE ANTEFLO

Model Number	GELWEAVE ANTEFLO
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative graft remains in situ within the patients anatomy; therfore no evaluation of the graft was possible.No clinical signs/symptoms or conditions were reported.Reported leakage event had no direct health consequence or impact.Material integrity problem reported.Site reported a leakage at the branch root in the device.Review of similar complaints of leakage for all gelsoft branded devices gave an information has ben requested from the clinician regarding the procedure.Analysis of production records - 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.Device remains implanted and will not be returned for further investigation.No issue was found with the manufacturing of the batch (based on the review of the retained production records).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
A gelweave anteflo device was reported to have leaked at the branch/body interface (branch root).The leaking site was sutured using prolene and the leak stopped.Small blood loss was reported, and 2 minutes extra surgery time was required to sew the leaking area.No patient harm or injury occurred.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE ANTEFLO
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11116331
• Report Number: 9612515-2021-00002
• Device Sequence Number: 11027805
• Product Code: DSY
• UDI-Device Identifier: 05037881106731
• UDI-Public: 05037881106731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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: 08/31/2022
• Device Model Number: GELWEAVE ANTEFLO
• Device Catalogue Number: 735028/8S-G
• Device Lot Number: 17980783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/05/2021
• 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