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

Model Number	GELWEAVE SIENNA PLEXUS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The site advised that the device is not available as it was remains in situ within the patients anatomy.(b)(4).Vascutek ltd.Considers this event as closed.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process, if an adverse trend develops action may be taken at that time.
Event or Problem Description
Reported graft leakage through the fibres which was located close to the anastomosis to the valsalva root.The area of bleeding on the graft and the anastomosis site was wrapped with another gelweave graft to apply pressure and sealants were also applied in-between the two grafts to help control the bleeding.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE SIENNA PLEXUS
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 12340799
• Report Number: 9612515-2021-00021
• Device Sequence Number: 3938729
• Product Code: DSY
• UDI-Device Identifier: 05037881997827
• UDI-Public: 05037881997827
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 02/29/2024
• Device Model Number: GELWEAVE SIENNA PLEXUS
• Device Catalogue Number: 73341088/8RM-G
• Device Lot Number: 21732105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/19/2021
• 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
• Patient Age: 53 YR