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

Catalog Number	73261088/8-G
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2025
Type of Reportable Event	Death
Event or Problem Description
During aortic surgery with vascutek gelweave 4 branch plexus 26 mm there was bleeding around the graft.Patient outcome is unknown at this time.
Additional Manufacturer Narrative
Clinical code 1888- hemorrhage/blood loss/bleeding: bleeding around the graft impact code 4648 - insufficient information: - unknown, no information provided yet.Medical device problem code 1250- fluid/blood leak- bleeding around the graft component code 4755 - part/component/sub-assembly term not applicable type of investigation 4111 - communication/interviews: additional questions have been asked for the complaint on 06 jan 26.3331 - analysis of production records: a review of manufacturing records was performed no issues were identified.Investigation findings 3233 - results pending completion of investigation investigation conclusion 11- conclusion not yet available.
Event or Problem Description
During aortic surgery with vascutek gelweave 4 branch plexus 26 mm there was bleeding around the graft.Patient outcome is unknown at this time this report is being submitted as follow up 2/ final for manufacturing report number 9612515-2026-00002 to provide event information for tag0378.
Additional Manufacturer Narrative
Clinical code.1888- hemorrhage/blood loss/bleeding: bleeding around the graft.Impact code.1802 -death- anaesthesiologist confirmed patient died.The cause of death was not provided.Multiple attempts were made however there was no information to state that the cause of death was related to this event.Medical device problem code.1250- fluid/blood leak- bleeding around the graft.Component code.4755 - part/component/sub-assembly term not applicable.Type of investigation: 4111 - communication/interviews: additional questions have been asked for the complaint on 06 jan 26.The gelatin coating on the graft appear intact and uniform.The leakage was on proximal anastomosis which was not stopping.No further information available 3331 - analysis of production records: a full batch review was performed for tag00378, and no issues were identified during manufacturing process from raw materials to finished products.4110- trend analysis- four year review was performed for gelweave sales jan 22 - nov 25 vs blood oozing> body type jan 22 - dec 25, occurrence rate is (b)(4) %.Investigation findings: 3221 - no findings available: there was no information/ scans available regarding this complaint, and hence the complaint is being closed with lack of information.Investigation conclusion: 4315- cause not established: no root cause could be identified due to lack of information.
Event or Problem Description
During aortic surgery with vascutek gelweave 4 branch plexus 26 mm there was bleeding around the graft.Patient outcome is unknown at this time.This report is being submitted as follow-up1 for manufacturing report number 9612515-2025-00002 to provide event information for (b)(4).
Additional Manufacturer Narrative
Clinical code 1888- hemorrhage/blood loss/bleeding: bleeding around the graft.Impact code 1802 -death- anaesthesiologist confirmed patient died.Medical device problem code 1250- fluid/blood leak- bleeding around the graft.Component code 4755 - part/component/sub-assembly term not applicable.Type of investigation 4111 - communication/interviews: additional questions have been asked for the complaint on 06 jan 26.The gelatin coating on the graft appear intact and uniform.The leakage was on proximal anastomosis which was not stopping.Awaiting further information 3331 - analysis of production records: a full batch review was performed for (b)(4), and no issues were identified during manufacturing process from raw materials to finished products.4110- trend analysis- four year review was performed for gelweave sales jan 22 - nov 25 vs blood oozing> body type jan 22 - dec 25, occurrence rate is (b)(4) %.Investigation findings 3233 - results pending completion of investigation.Investigation conclusion.11- conclusion not yet available.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE BRANCH 4 PLEXUS
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 24066640
• Report Number: 9612515-2026-00002
• Device Sequence Number: 9380903
• Product Code: DSY
• UDI-Device Identifier: 05037881106335
• UDI-Public: 05037881106335
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K090987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: 07/31/2026
• Device Catalogue Number: 73261088/8-G
• Device Lot Number: 25383229
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 12/18/2025
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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: Death; Other
• Patient Sex: Male