MAUDE Adverse Event Report: Vascutek Ltd. Gelweave; Gelweave Siena Collared 4 Branch Plexus with Radiopaque Markers

Catalog Number	73261088/10RM-J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Blood leakage: blood leakage was identified at the anastomosis between the collar and the main vessel graft.There were no issues during cardiopulmonary bypass.However, after the aortic cross-clamp was released, bleeding occurred and could not be stopped.Hemostasis was achieved by using a large amount of haemostatic agents.Then, the chest was closed.Although the procedure time was extended due to the time it took to achieve hemostasis, the procedure was successfully completed.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: e 1888 - haemorrhage/ bleeding -blood leaking from the collar area of the plexus device.Impact code: f 4632- prolonged surgery - surgery was extended due to having to apply haemostatic agent to stop the leakage.Device problem code :a 1250 - fluid/blood leak- blood leaking from the collar area of the plexus device component code: g 4755 - part/component/sub-assembly term not applicable type of investigation: b 4109 - historical data analysis: -a four year similar event review could not be performed for this event as this is the first event of leakage from the sewn collar area of the plexus device jan 22 - sep 26.4112 - analysis of information provided by user/third party: additional information has been requested to aid this investigation.3331 - analysis of production records: full batch review performed from base fabric to finished product for device id- 25833447 which confirmed the batch was manufactured to specification.4117 - device not returned: device remains implanted investigation findings: c 3233 - results pending completion of investigation investigation conclusion: d 11 - conclusion not yet available as investigation is ongoing.

• Brand Name: Gelweave
• Common Device Name: Gelweave Siena Collared 4 Branch Plexus with Radiopaque Markers
• Manufacturer (Section D): Vascutek Ltd.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): Vascutek Ltd.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 50730737
• Report Number: 9612515-2026-00060
• Device Sequence Number: 10633978
• Product Code: DSY
• UDI-Device Identifier: 05037881997780
• UDI-Public: 05037881997780
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Catalogue Number: 73261088/10RM-J
• Device Lot Number: 25833447
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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 Sex: Unknown