MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED AXILLO RS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HGKAX080606RS35/20
Medical Device Problem Codes	Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturer narrative: at time of this report, no injury information was reported to intervascular.We are in contact with the hospital to inquire about the patient's state of health.(4117) device is not accessible for testing as it remained implanted in the patient.(4111/3233) the investigation involved communication with persons close to the event to have more information, answers are pending.(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 a hospital implanted an expired polyester bifurcated graft 3 months past its expiration date on a patient.No injury was reported at the time of this report.

• Brand Name: HEMAGARD KNITTED AXILLO RS
• 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: 25147552
• Report Number: 1640201-2026-0000028
• Device Sequence Number: 9323954
• Product Code: DSY
• UDI-Device Identifier: 00384401014430
• UDI-Public: (01)00384401014430
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 02/28/2026
• Device Model Number: HGKAX080606RS35/20
• Device Catalogue Number: HGKAX080606RS35/20
• Device Lot Number: 21C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown