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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Event reported as part of panther study (b)(6) on (b)(6) 2024.The event was reported as aneurysm, and reported as possibly device related.Suture aneurysm in the area of the proximal anastomosis in the event of state: implantation of an aortoiliac bifurcation prosthesis on 04 november 21.Reintervention required: evar (understood to be endovascular aortic repair) aortoiliac (b)(6) 2023.Patient recovered, resolved without sequelae.This event was reported to complaints department on 07 feb 24, however the event was not raised at this time.After review the event was raised on 26 aug 24.An internal non conformance has been raised to investigate this late reporting and provide preventative actions if required.
Additional Manufacturer Narrative
Clinical code ( e ) 1708 - aneurysm - suture aneurysm at the area of the proximal anastomosis.Impact code ( f ) 4625 - additional surgery - evar (understood to be endovascular aortic repair) aortoiliac (b)(6) 2023.Medical device problem code ( a ): 3190 - insufficient information - not enough information has been provided in order to establish a connection between the device and the event as described.Component code ( g ): 4755 - part/component/sub-assembly term not applicable.Type of investigation ( b ): 4118 - type of investigation not yet determined - no investigation has been performed yet as of time of writing.Investigation findings ( c ): 3233 - results pending completion of investigation.Investigation conclusion ( d ): 11 - conclusion not yet available.A conclusion has yet to be established as the investigation is incomplete.
Event or Problem Description
Event reported as part of panther study (b)(4) on (b)(6) 2024.The event was reported as aneurysm and reported as possibly device related.Suture aneurysm in the area of the proximal anastomosis in the event of state: implantation of an aortoiliac bifurcation prosthesis on (b)(6) 2021.Reintervention required: evar (understood to be endovascular aortic repair) aortoiliac (b)(6) 2023.Patient recovered, resolved without sequelae.This event was reported to complaints department on (b)(6) 2024, however the event was not raised at this time.After review the event was raised on (b)(6) 2024.An internal non-conformance has been raised to investigate this late reporting and provide preventative actions if required.This event is being submitted as a follow up #1 for mfg report number 9612515-2024-00061 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Clinical code (e).1708 - aneurysm - suture aneurysm at the area of the proximal anastomosis.Impact code (f).4625 - additional surgery - evar (understood to be endovascular aortic repair) aortoiliac (b)(6) 2023/ medical device problem code (a).2993 - adverse event without identified device or use problem- no apparent failure of the device was identified during the investigation, and no causal link between the event and the device was determined.Component code (g).4755 - part/component/sub-assembly term not applicable.Type of investigation (b).4110- trend analysis- a trend analysis was performed, which showed that this event was the first failure of medical event > aneurysm in a gelweave device in the last 4 years.No trend was identified requiring action at this time.4111- communication/ interviews- information received from the complainant on (b)(6) 2024 confirmed that there was no suspected device deficiency, no rupture was observed, and no endoleak was observed until after intervention for the aneurysm.4117- device not accessible for testing- the device remains implanted.3331- analysis of production records- a full batch review from raw material to finished product has been completed which showed no issues during the manufacturing process.4112- analysis of data provided by user/ third party- a review of patient scans from (b)(6) 2023 was conducted.An assessment of the imaging dictated a difference of 5mm in diameter between the native aorta (~29mm) and the graft (~24mm).There is no pre-op imaging available to determine if this variance was initially present or if there has been dilatation of the aorta over time.Dilatation of the aorta may lead to disruption of the anastomosis, eventually resulting in aneurysm.There is no apparent device failure identified in the imaging.Investigation findings (c).213- no device problem found- as no apparent failure of the device was identified during the investigation of this event, and no preoperative imaging has been provided to determine if the dilation of the aorta was initially present after operation or has occurred over time, no root cause was able to be determined for this event, and no causal link between the device and the event could be found.Investigation conclusion (d).4315- cause not established- no causal link between the event and the device could be determined.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 20075761
• Report Number: 9612515-2024-00061
• Device Sequence Number: 19601778
• Product Code: DSY
• UDI-Device Identifier: 05037881105857
• UDI-Public: 05037881105857
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K964665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 732412-G
• Device Lot Number: 21773761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 80 YR
• Patient Sex: Male