MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE 4 BRANCH PLEXUS

Model Number	GELWEAVE 4 BRANCH PLEXUS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method code: manufacturing review.Quality review.Photographic inspection (video content was provided by the distributor that illustrated the leak whilst in-situ within the patient).Results code: the review of the retained quality, manufacturing records confirmed that the product was manufactured to the intended specifications.Although the video footage illustrated the leak originated from the graft (branch root), no determination of the cause was possible.Conclusion code: device not returned.- vascutek has been informed that the affected graft is not available for evaluation.Vascutek has requested additional information regarding the circumstances of the event and the status of the affected device.We are awaiting responses to our enquiries.
Event or Problem Description
During the implant procedure, blood was oozing / seeping from a branch root.The distributor advised that the leaking graft was explanted and replaced with an unknown graft.The procedure was completed without any further issues.
Additional Manufacturer Narrative
Unable to confirm complaint - the affected device or any units from the remaining batch were not available for evaluation and testing.A complete review of the quality and manufacturing records did not identify any issues; therefore no root cause was identified for the reported defect.Video evidence from the distributor illustrated the leakage and its location within the graft, however as the affected device was discarded by the reporting site, no physical analysis of the device was possible.No units from the remainder of the batch were available for testing.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 and its associated batch were manufactured to the intended specifications.A 5-year review of similar events (woven type polyester grafts leakage complaints) indicated an incidence rate of 0.02% (complaints v's sales); with no other reported events from the remainder of the batch.A review of ncr's identified no negative trends; similarly, no applicable capa activity was identified.No root cause was identified for the reported defect (complaint unconfirmed).Vascutek now consider this event closed; however, the event type will continue to be tracked and trended through the complaint's monitoring system.If a negative trend arises corrective actions may be considered at the time.
Event or Problem Description
Update: the distributor advised that the leaking graft was explanted and replaced with another vascutek ltd.Manufactured gelweavetm four branch plexus device.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE 4 BRANCH PLEXUS
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6793636
• Report Number: 9612515-2017-00012
• Device Sequence Number: 13485212
• Product Code: DSY
• UDI-Device Identifier: 05037881106335
• UDI-Public: 05037881106335
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K090987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017
• Report Date (Section F): 08/03/2017

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: 09/30/2021
• Device Model Number: GELWEAVE 4 BRANCH PLEXUS
• Device Catalogue Number: 73261088/8
• Device Lot Number: 15876002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2017
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 10/25/2017
• 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