MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE BIFURCATE

Model Number GELWEAVE BIFURCATE

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

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 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
• Type of Device: GELWEAVE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 11884304
• MDR Text Key: 254821422
• Report Number: 9612515-2021-00016
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105819
• UDI-Public: 05037881105819
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K964665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention