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

Model Number	732010XL55
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
This event was reported to vascutek ltd via the panther study programme as follows: on (b)(6) 22 a gelweave bifurcate extra long graft was implanted to treat aorto-iliac stenosis.After procedure an occlusion of the right leg was detected.The patient underwent a thrombectomy of the right leg and femoro-popliteo-jambiere.The issue was considered resolved without sequalae.Patient recovered.The site has indicated that this event is possibly related to the procedure, device and patient pre-existing conditions.
Additional Manufacturer Narrative
Section h6 investigation findings: 3221 - no findings available - additional information about the event was requested from the study site on (b)(6) 2022.(b)(6) 2022-09-30, 2022-10-17; however no further information was provided investigation conclusions: 67 - no problem detected - review of the manufacturing records did not identify any problems with the device.4315 - cause not established - the root cause of the event could not be determined, due to lack of information provided.Patient recovered.Adverse event resolved without sequelae.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.
Event or Problem Description
This report is being submitted as follow up #1 for mfg.Report # 9612515-2022-00013 to provide event closure information.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE BIFURCATE
• 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: jason whittle ; newmains avenue; inchinnan business park; renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 15435951
• Report Number: 9612515-2022-00013
• Device Sequence Number: 6071197
• Product Code: DSY
• UDI-Device Identifier: 05037881107653
• UDI-Public: 05037881107653
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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?: No
• Device Expiration Date: 01/31/2024
• Device Model Number: 732010XL55
• Device Catalogue Number: 732010XL55-G
• Device Lot Number: 21658483
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male