MAUDE Adverse Event Report: Vascutek LTD Gelweave 4 branch Plexus; Gelweave Plexus

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 1888 - hemorrhage/blood loss/bleeding: site reported the event as blood leakage from body of the graft.Impact code: 4641 - unexpected medical intervention: the doctor used a surgiflo (johnson & johnson), a hemostatic agent, to address the leakage.Hemostasis was achieved and the procedure was completed.Medical device code : 1250 - fluid/blood leak: site reported the event as blood leakage from body of the graft component code: 4755 - part/component/sub-assembly term not applicable: type of investigation: 4110 - trend analysis: four year review was performed for gelweave > leakage > blood oozing > body, this gave an occurrence score of 0.001%.No trend requiring action at this time.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.22 - known inherent risk of device: ifu (instructions for use) review confirmed that within japan gelweave ifu (vascutek_gelweave_ver15_eng) mentions bleeding within serious adverse events section.
Event or Problem Description
Event reported as blood leakage, after performing the distal anastomosis, the doctor checked for hemostasis.However, leakage was observed from the main body of the graft.The doctor used a surgiflo (johnson & johnson), a hemostatic agent, to address the leakage.Hemostasis was achieved and the procedure was completed.

• Brand Name: Gelweave 4 branch Plexus
• Common Device Name: Gelweave Plexus
• Manufacturer (Section D): Vascutek LTD; newmains avenue; inchinnan buiness 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: 25677531
• Report Number: 9612515-2026-00033
• Device Sequence Number: 14651943
• Product Code: DSY
• UDI-Device Identifier: 05037881998459
• UDI-Public: 05037881998459
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090987
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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 Model Number: N/A
• Device Catalogue Number: 73261088/10SA-J
• Device Lot Number: 26140853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: Other
• Patient Sex: Unknown