MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT PLUS

Catalog Number	632010DB
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/18/2018
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 (b)(4) passed porosity testing well below acceptance limit of 152ml/min with minimum reading of 23ml/min and highest reading of 28ml/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 0.019% (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.
Event or Problem Description
Vascutek ltd was notified of an event that occurred in (b)(6), the event was described as follows: on (b)(6) 2017: the graft was implanted for abdominal aortic aneurysm (aaa).On (b)(6) 2018: the patient visited the hospital complaining about pain.The departments of cardiovascular surgery and radiology identified blood leakage from the leftmost one of the gelsoft branches by ct scanning.A stent graft was then added to the leakage area.
Additional Manufacturer Narrative
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.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.
Event or Problem Description
This report is being submitter as follow up#1 for mfr.Report # 9612515-2018-00020 to provide closure information for the case.

• Brand Name: GELSOFT
• 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: 7974072
• Report Number: 9612515-2018-00020
• Device Sequence Number: 19243752
• Product Code: MAL
• UDI-Device Identifier: 05037881110028
• UDI-Public: 05037881110028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P890045/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018
• Report Date (Section F): 09/21/2018

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: 07/31/2021
• Device Catalogue Number: 632010DB
• Device Lot Number: 390278 9150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 10/26/2018
• 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