MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS

Catalog Number	631608P
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the retained manufacturing and quality records (with specific emphasis of the base material permeability and device porosity testing) confirmed that the product was manufactured to the intended specifications.The whole batch of 9 passed porosity testing well below acceptance limit of 77ml/min with minimum reading of 1ml/min and highest reading of 6ml/min.A review of similar events was performed for all knitted devices that have been reported to have leaked.The incident rate for reported leakage events was confirmed as (b)(4)% (complaints v sales).The review included all similar events reported to vascutek between jan2013 - sep 2018 inclusive.No negative trend was identified during the review.The distributor informed vascutek that the device would not be made available as it remains in situ within the patient's anatomy, therefore no analysis of the device is possible.As further device analysis is not possible, and graft met all acceptance criteria during testing, vascutek ltd consider this event closed.
Event or Problem Description
Vascutek ltd.Was notified of an event that occurred in (b)(6), the event was described as follows: the prosthesis after being implanted in the patient showed a tear in the union of bifurcation.During surgery the graft presents blood leak with a slight narrow and unusual jet, the surgeon proceeds to suture the tear and solves the event, leaving the prosthesis in the patient.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7977048
• Report Number: 9612515-2018-00021
• Device Sequence Number: 1093639
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2018
• Report Date (Section F): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 631608P
• Device Lot Number: 16991563 0505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2018
• 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
• Patient Age: 76 YR