MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Catalog Number	631608P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: historical data analysis - similar events review was carried out.Analysis of production records - relevant dhr and qc test records reviewed.Insufficient information available - additional information requested from the customer.Awaiting device return.Results: results pending completion of investigation.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 six passed porosity testing well below acceptance limit of 77ml/min with minimum reading of 0ml/min and highest reading of 05ml/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 (b)(4) 2013 - (b)(4) 2018 inclusive.No negative trend was identified during the review.Additional information on the event was requested from the customer for further event investigation.Investigation results will be communicated in follow up / final report.
Event or Problem Description
Vascutek ltd.Was notified of an event that occurred in usa, the event was described as follows: graft was leaking at the point of bifurcation after being implanted.Leak occurred during cardiopulmonary bypass.
Event or Problem Description
This report is being submitted as final narrative for mfr.Report # 9612515-2018-00024 to provide closure information for the case.
Additional Manufacturer Narrative
3221 - no finding available.Conclusion: 4315 - cause not established.Although the customer returned the graft for further investigation, vascutek ltd could not identify the root cause of the event.As per the event intake form, the graft was initially implanted and then explanted when a leak at the bifurcation was identified.The storage conditions between explant and return (three month later) are unknown.Upon receipt of the graft, it was expected that the graft had been sent back unmodified and blood stained; however, it appeared that the graft had been cleaned after implant with an unknown solution before return.As a result, any further testing was deemed inconclusive.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.Vascutek ltd consider this case closed.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8141128
• Report Number: 9612515-2018-00024
• Device Sequence Number: 13690595
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018
• Report Date (Section F): 12/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 631608P
• Device Lot Number: 17096509 0986
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2018
• Initial Date Received by Manufacturer: 12/02/2018
• Supplement Date Received by Manufacturer: 12/02/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 04/15/2019
• 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: Hospitalization