BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD KNITTED VASCULAR PROSTHESIS

    MDR report key: 1241243 · Received November 4, 2008

    Report

    Report Number
    1640201-2008-00018
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 3, 2008
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FACILITY NUMBER HAD BEEN ASSIGNED TO THIS REPORT. NO DEVICE EVALUATION WAS PERFORMED SINCE THE GRAFT REMAINED IMPLANTED IN PATIENT. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, NO ANOMALY WAS FOUND IN THE COLLAGEN COATING RECORDS OR IN THE SEWING RECORDS. ONE PRODUCT COATED THE SAME DAY THAN THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING. TESTS RESULTS INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. NO LEAKAGE WAS OBSERVED AT THE BIFURCATION AREA. NO CONCLUSION CAN BE DRAWN. HOWEVER, A REVIEW OF THE INTERVASCULAR POST MARKETING DATA AND THE TESTING PERFORMED ON SIMILAR PRODUCTS WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ABDOMINAL VASCULAR PROCEDURE. DURING THE PROCEDURE, BLEEDING WAS EVIDENCED AT THE BIFURCATION OF THE GRAFT. BLEEDING WAS STOPPED BY ADDITIONAL SUTURING. GRAFT REMAINED IMPLANTED IN THE PATIENT. PATIENT WAS REPORTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD KNITTED VASCULAR PROSTHESIS DSY INTERVASCULAR IGK1608 07D05

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention