MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE 4 BRANCH PLEXUS

Model Number GELWEAVE 4 BRANCH PLEXUS

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A 5 year review of similar complaints which included polyester product issues for structural defects/specification gave a low occurrence rate of 0.01% (complaints v sales).No negative trend in the number of complaints received was identified.The complaint device was manufactured in batch of 1; therefore, no other devices affected from the same batch.A full review of the dhr identified a discrepancy with the sewing verification step, whereby it was verified by the same individual performing the sewing operation.A review of manufacturing processes identified potential areas for improvement, through update of the procedure, dhr and associated drawing.Immediate actions have been assigned for the awareness of personnel involved in the manufacture and inspection processes to use the final product drawings at each process step.The issue with this device has been confirmed as a manufacturing defect, which was not identified during inspection process in place.The root cause was identified as an error during sewing process, not detected at subsequent process steps, as the drawing was not correctly followed.Improvement actions have been identified (procedure, product drawing, dhr updates) and will be implemented within the next month.

Event Description

The event was reported as follows: when anastomosis of the graft to another graft was being performed after stepwise technique was performed clinician noticed that branches on the gelweave 4 branch plexus device were sewn in the incorrect positions.The procedure continued with the device and was successfully completed.

Manufacturer Narrative

Conclustion updated code: 143 - quality control deficiency - manufacturing error was not detected at any step during inspection process.Update on the corrective actions that were carried out in november 2017 - october 2018: 1.Group awareness training was delivered to operators in cr1 (polyester inspection) and cr8 (polyester sewing), with reinforcement for the independent verification as stated in procedure cpp011 (sewing of ante-flo and straight grafts).The operator responsible for manufacturing the complaint graft was given individual awareness training.2.(b)(4) (polyester product inspection) rewritten for clarification and ease of use in december 2017 and is applicable to all polyester in-process production inspection (cr1).An additional inspection is now carried out by the process quality assurance team (pqa) team.As part of the updated procedure, daily random inspection of finished polyester product prior to packaging was introduced.3.After an internal review, it was decided that the dhr and pack drawing will not be updated for consistency of polyester grafts manufacturing and to minimise an impact on oem products.There have been no further complaints of wrong branch orientation in polyester grafts since complaint (b)(4).Further action is not planned; 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.The investigation and all other complaint activities have been completed; therefore, the file can be closed.

Event Description

This report is being submitted as final narrative for mfr.Report # 9612515-2017-00022 to provide closure information for the case.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE 4 BRANCH PLEXUS
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7016897
• MDR Text Key: 92683147
• Report Number: 9612515-2017-00022
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881002545
• UDI-Public: 05037881002545
• Combination Product (y/n): N
• PMA/PMN Number: K040829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/12/2017,01/09/2019

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
• Device Operator: Physician
• Device Expiration Date: 04/30/2021
• Device Model Number: GELWEAVE 4 BRANCH PLEXUS
• Device Catalogue Number: 73201088/10SA
• Device Lot Number: 384064-8846
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2017
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2017
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1