MAUDE Adverse Event Report: Intervascular SAS Hemashield; Graft, Vascular, Synthetic/Biologic Composite

Model Number	M002020852010
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that on (b)(6) 2021, an abdominal aortic graft replacement surgery was performed using hemashield.A 20mm portion of the 20mm x 10mm graft was used to perform an i-shaped replacement in the area from the infrarenal artery to the terminal aorta.The distal end of the i-shaped graft was anastomosed to the left common iliac artery, and a propaten 8mm ring, end-to-end anastomosed to the i-shaped portion, was anastomosed to the right external iliac artery.One week after the replacement surgery, on (b)(6) 2021, the graft had expanded to 28mm (the entire 20mm graft was expanded), and a large amount of mural thrombus was observed.Further expansion continued thereafter, reaching 32.4mm at 5 years post-surgery.Thrombus was prominently observed distal to the propaten bifurcation.Complaint # (b)(4).
Additional Manufacturer Narrative
(4117) based on the initial information the involved device remained implanted.(4111/3233) attempts to contact the initial reporter to obtain additional information and the patient¿s current status are ongoing.(3331/3233) the device history records review is ongoing.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 19d17.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

• Brand Name: Hemashield
• Common Device Name: Graft, Vascular, Synthetic/Biologic Composite
• Manufacturer (Section D): Intervascular SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): Intervascular SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; +033()442084646
• MDR Report Key: 50911465
• Report Number: 1640201-2026-0000043
• Device Sequence Number: 17586649
• Product Code: MAL
• UDI-Device Identifier: 00384401017776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Expiration Date: 03/31/2024
• Device Model Number: M002020852010
• Device Catalogue Number: M002020852010
• Device Lot Number: 19D17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Propaten.
• Patient Sex: Male
• Patient Weight: 371 LB