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

Model Number	IGK0010-40
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that the customer alleged that humidity levels were over 80% for more than 24 hours and did reach 100%.The distributor, intermed had one of reps visit the customer site for an on-site inspection of the products.Some products had bubbling on the labelling.It was described that all products felt cold as if like they were defrosted.It was suspected that the products were exposed to extremely high levels of moisture.The impacted products include 12 intervascular hemagard and intergard grafts.Twelve separate complaints were created for each affected products.Accordingly, twelve individual emdr submissions will be submitted.This emdr is part of a series of twelve emdrs submitted for the same event.
Additional Manufacturer Narrative
(4114) the actual device involved in the event was not returned for testing despite requests by manufacturer.Intervascular informed the customer that the affected products must not be used.Exposure to such environmental conditions may compromise product integrity and sterility.(4111/193/4308) based on the analysis of the information provided, the root cause of the adverse event is related to a storage issue at customer site.Indeed, all products have been stored in the hospital since january, and the humidity excursion was reported at the customer site.As indicated in the product ifu, the storage section states:"store in a dry, dust-free conditions at a temperature not exceeding 25°c".

• Brand Name: INTERGARD KNITTED 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: 24715127
• Report Number: 1640201-2026-0000016
• Device Sequence Number: 20253252
• Product Code: DSY
• UDI-Device Identifier: 00384401000389
• UDI-Public: (01)00384401000389
• 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: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: IGK0010-40
• Device Catalogue Number: IGK0010-40
• Device Lot Number: 24M19
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown