MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE VALSALVA ANTE-FLO

Catalog Number	734028/10ADP
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No known impact or consequence to patient: no reported significant delay to procedure, patient consequence or harm.Bleeding was halted with application of suture and patient reported as stable post op.Material integrity problem.Material puncture / hole : reported as leakage from hole in the body of the graft.Historical data analysis: a 5-year review of previous gelweave complaints for hole in the graft was carried out and gave an occurrence rate of 0.003%.Analysis of production records: review of retained qc, manufacturing and physical testing records performed: a review of retained qc and manufacturing records showed that this batch was manufactured to specification with no issues raised.A review of the graft base material physical tests showed all testing met acceptance criteria.Base material porosity tests and finished product porosity tests were all within specification with no issues highlighted.Device not accessible for testing: device remains implanted in patient and will not be returned for testing.No device problem found: review of product batch records showed no issue with the manufacture of this batch.Cause not established - cause of the leakage could not be established from review of qc and manufacturing records.Vascutek ltd.Is submitting this report as an initial/final report.No further information available and no investigation is possible as device remains implanted.Vascutek ltd.Now considers this complaint closed 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
The event was reported as follows: when the physician was anastomosing the distal end of the graft, the physician observed that the graft had a hole which was much bigger than a pin hole.The physician sutured the hole.The procedure was successfully completed.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE VALSALVA ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 9254300
• Report Number: 9612515-2019-00026
• Device Sequence Number: 11412914
• Product Code: DSY
• UDI-Device Identifier: 05037881121031
• UDI-Public: 05037881121031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2019
• Report Date (Section F): 10/04/2019

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: 04/30/2023
• Device Catalogue Number: 734028/10ADP
• Device Lot Number: 17299171 1042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2019
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/30/2019
• 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