BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED GRAFT

    MDR report key: 3954600 · Received July 16, 2014

    Report

    Report Number
    1640201-2014-00024
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INTERVASCULAR, SAS
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFORMATION CONTAINED IN THIS REPORT IS PROVIDED BY THE MANUFACTURER. ((B)(4)) A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING OF PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. ((B)(4)) ONE RETENTION SAMPLE COATED ON THE SAME PERIOD AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING AT (B)(4) AS PER ISO 7198. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS. PLEASE NOTE THAT THE DEVICE WAS NOT USED IN AN APPROVED INDICATION. NO CONCLUSION CAN BE DRAWN. HOWEVER, ALL AVAILABLE INFORMATION AND THE PRODUCT TESTING PERFORMED WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    DURING AN AORTIC SURGERY USING A HEMASHIELD WOVEN AORTIC ARCH PERFORMED ON (B)(6) 2014. AN INTERGARD GRAFT WAS USED TO HELP CANNULA ACCESS. WHEN THE SURGEON OPENED THE CLAMPS, THE INTERGARD GRAFT STARTED WEEPING. AFTER 2 HOURS OF PROCEDURE, THE WEEP DECREASED A LITTLE. AFTER DISCONTINUATION OF EXTRACORPOREAL SUPPORT, THE GRAFT WAS REMOVED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416057 INTERGARD KNITTED GRAFT VASCULAR GRAFT PROSTHESIS DSY INTERVASCULAR, SAS IGK0007-70 11H18

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other