MAUDE Adverse Event Report: Intervascular SAS Intergard Woven Aortic Arch; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Model Number	HEWAA3010080810/1
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint #(b)(4).
Additional Manufacturer Narrative
(10/213) the returned product was visually inspected by the quality assurance (qa) supervisor.The analysis of the product confirms the presence of the yellow stains on the graft surface.Such spots are a known occurrence, and it can be confirmed that they are caused by collagen.But this is a known phenomenon that doesn't affect the product's performance or safety if no additional thickness is visible on the product, which is the case for the product.The product therefore complies with the specifications.(67) based on the investigation findings, it was concluded that the involved product is conform to the product specifications.

• Brand Name: Intergard Woven Aortic Arch
• Common Device Name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• 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: 50173515
• Report Number: 1640201-2026-0000037
• Device Sequence Number: 9880594
• Product Code: DSY
• UDI-Device Identifier: 00384401010760
• UDI-Public: (01)00384401010760
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K013651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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 Model Number: HEWAA3010080810/1
• Device Catalogue Number: HEWAA3010080810/1
• Device Lot Number: 24L14
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown