MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE

Model Number GELWEAVE ANTE-FLO

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Fungal Infection (2419)

Event Date 09/18/2017

Event Type  Injury  

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 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
• Type of Device: GELWEAVE
• 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: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 6972570
• MDR Text Key: 90063472
• Report Number: 9612515-2017-00019
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881106144
• UDI-Public: 05037881106144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040829
• 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: 09/25/2017,10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• 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
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention