BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED GRAFT

    MDR report key: 4332280 · Received December 3, 2014

    Report

    Report Number
    1640201-2014-00034
    Event Type
    Injury
    Date Received
    December 3, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 10, 2014
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFO CONTAINED IN THIS REPORT IS PROVIDED BY THE MFR. 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 RECORDS OF PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. ONE RETENTION SAMPLE COATED ON THE SAME PERIOD AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING AT 120 MMHG AS APER ISO 7198. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS. THE DEVICE WAS NOT USED IN AN APPROVED INDICATION. NO CONCLUSION CAN BE DRAWN. HOWEVER, ALL AVAILABLE INFO AND THE PRODUCT TESTING PERFORMED WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    DURING AN AORTIC VALVE REPLACEMENT PERFORMED ON (B)(6) 2014, THE INVOLVED GRAFT WAS ANASTOMOSED TO THE SUBCLAVIAN ARTERY AND CONNECTED TO AN ARTIFICIAL HEART-LUNG MACHINE FOR BLOOD TRANSMISSION. DURING THE EXTRA CORPOREAL CIRCULATION, THE GRAFT WAS REPORTED TO LEAK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779638 INTERGARD KNITTED GRAFT VASCULAR GRAFT PROSTHESIS DSY INTERVASCULAR IGK0008-70 13K17

    Patients

    Seq Age Sex Outcome Treatment
    1 Other