MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE

Model Number	GELWEAVE ANTE-FLO
Medical Device Problem Code	Device Contamination With Biological Material (2908)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An investigation was completed which showed no issues or adverse trends.The review of manufacturing, qc and sterilisation records confirmed that the graft was manufactured and sterilised to specifications.A 5-year review of similar events was carried out that covered complaints for all product and gave a very low occurrence rate of 0.001% (complaints v sales).Similar events review only for gelweave product family also gave a low occurrence rate of 0.002%.However, none of the reported events were confirmed to have been device related.There have been no similar events reported for any units which were in the same sterilisation run as the complaint graft.A report was completed by the microbiology team which reviewed the environmental monitoring results, bioburden levels, endotoxin results, active air sampling results and particle count data from the period the complaint device was manufactured.The review confirmed that all test results were within specification and no unusual isolates were recovered.It was confirmed by microbiology team that the bipolaris species of mould is not present in (b)(6).It is mainly found in tropical areas; therefore, we do not believe that graft was contaminated at our facility.The root cause of the event was not identified.Further action is not planned; however, the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.Vascutek consider this case closed.
Event or Problem Description
The event was described as follows: graft was implanted on (b)(6) 2016.Sorin perfusion equipment and edward's valve were used during original procedure.Following graft implant patient had a few procedures and surgeries.W/c (b)(6) 2017 complaint graft was explanted.The pathology report from the graft showed presence of mould (bipolaris species).

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6972570
• Report Number: 9612515-2017-00019
• Device Sequence Number: 444158
• Product Code: DSY
• UDI-Device Identifier: 05037881106144
• UDI-Public: 05037881106144
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2017
• Report Date (Section F): 09/25/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: GELWEAVE ANTE-FLO
• Device Catalogue Number: 734034/10
• Device Lot Number: 370640-8282
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2017
• Device Age: 23 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/24/2017
• 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