MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE STRAIGHT

Model Number	N/A
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Stroke/CVA (1770); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 1770 - stroke/cva: it was reported that the patient had suffered from 7 strokes.Impact code: 4618 - permanent impairment: the patient was left permanently blind and inability to work.Medical device problem: 3190 - insufficient device problem information: awaiting further information.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: four year review was performed for gelweave > medical event > stroke (b)(6) 2022 - (b)(6) 2026, unfortunately no statistical analysis could be performed, this is due to a first time occurrence for this event.Investigation findings: 3233 - results pending completion of investigation: investigation conclusion: 11 - conclusion not yet available: additional information: this incident was received from the patient's legal representative.No adverse event has been reported by the physician from the site.
Event or Problem Description
Incident was received from the patient's legal representative and a summary of the incident information is stated below: on the evening of (b)(6) 2024, a few hours after the intervention described as "replacement of the ascending aorta with a dacron prosthesis of 38 mm diameter with reinforcement of proximal and distal anastomoses using acuseal strips and bio glue surgical adhesive under extracorporeal circulation (ecc)," my wife began receiving automatic sms messages stating, "mri stroke." as no one had informed her that i was in a serious, unconscious condition, she called the hospital, where icu staff informed her that, i had suffered 7 strokes."considering the cardio-embolic nature of the events, the number of 7 strokes, and the context of surgery involving implantation of prosthetic materials and use of surgical adhesives, there is a high medical probability that the embolic source was the formation of a thrombus directly related to the implanted medical devices or their material.As a result of the incident the patient is reporting an "inability to work and permanent blindness".This event occured when the patient was hospitalised in (b)(6).

• Brand Name: GELWEAVE STRAIGHT
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 25158761
• Report Number: 9612515-2026-00019
• Device Sequence Number: 21195634
• Product Code: DSY
• UDI-Device Identifier: 05037881105048
• UDI-Public: 05037881105048
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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 Model Number: N/A
• Device Catalogue Number: 732038-G
• Device Lot Number: 25386917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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: Disability; Other
• Patient Sex: Unknown