MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE PLEXUS

Model Number	GELWEAVE PLEXUS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturers narrative: device not evaluated by manufacturer - device repaired using tacho seal and remains implanted in patient.(b)(4).Device was reported to be oozing blood when circulation was restarted after implant.Review of manufacturing and qc records confirmed that the device was manufactured to specification.Sterilisation process review - review of the sterilisation records for the device confirmed there were no issues with sterilisation of device.No failure detected - vascutek's review has confirmed that there was no issue with the manufacture of the device.Manufactured to design specification.No results since no evaluation - the actual graft remains in situ and therefore is not available for manufacturer inspection.No further information is available from site regarding this event.Vascutek have carried out a review of similar events and the occurrence rate for this type of defect is found to be (b)(4) and therefore is very low.Vascutek now consider this case closed however the event type will be tracked and trended through the complaints monitoring program and if an adverse trend is identified corrective action may be considered at that time.
Event or Problem Description
The graft in question was implanted and circulation restarted.After a while the graft started to ooze blood at sutured segment between branch and the main trunk.Tacho seal was applied to stop bleeding.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• MDR Report Key: 5982732
• Report Number: 9612515-2016-00025
• Device Sequence Number: 1641239
• Product Code: DSY
• UDI-Device Identifier: 05037881998473
• UDI-Public: 05037881998473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2016
• Report Date (Section F): 09/02/2016

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: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: GELWEAVE PLEXUS
• Device Catalogue Number: 73221088/10SA
• Device Lot Number: 372149
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/29/2016
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 09/28/2016
• 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