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

Model Number	IGW0032-30
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) it was reported that the product is available.Currently, the shipping process is ongoing.A visual product inspection is scheduled.(4109/3233) the review of historical data indicates that no other similar complaint was reported on the same sterilization lot number 23m07 (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 that the product in question was opened before surgery, and yellow spots were detected on the graft during the procedure.To ensure patient safety, the doctor did not use it.A new product was opened and used, and no problems occurred.
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 spots 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 product specifications.
Event or Problem Description
Complaint # (b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT
• 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: 23508931
• Report Number: 1640201-2025-0000030
• Device Sequence Number: 9877580
• Product Code: DSY
• UDI-Device Identifier: 00384401000280
• UDI-Public: (01)00384401000280
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: IGW0032-30
• Device Catalogue Number: IGW0032-30
• Device Lot Number: 23M07
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown