MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	IGW0026-15
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number 23k19.(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination (11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular from the health facility that the doctor found there was a yellow like stain on the surface of the graft.Another graft was used to complete the surgery.Complaint # (b)(4).
Event or Problem Description
Complaint # (b)(4).
Additional Manufacturer Narrative
(10/213) the involved device was returned to intervascular.A visual inspection was performed by the quality assurance supervisor.The inspection results are the following: the visual inspection of the returned product confirmed the presence of yellow stains on its outer surface.The observed spots are a known phenomenon caused by collagen during the prosthesis manufacturing process; they may develop a yellowish tint over time but do not impact product safety or performance, and the product remains compliant with its specifications.(67) the conducted investigation concludes that the returned product is conform to the the product specifications.

• Brand Name: INTERGARD WOVEN
• 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 ; 442084646
• MDR Report Key: 23368425
• Report Number: 1640201-2025-0000027
• Device Sequence Number: 21061732
• Product Code: DSY
• UDI-Device Identifier: 00384401000211
• UDI-Public: (01)00384401000211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: IGW0026-15
• Device Catalogue Number: IGW0026-15
• Device Lot Number: 23K19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown