BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IGK1608-IGK 1608 INTERGARD KNITTED GRAFT

    MDR report key: 322212 · Received March 21, 2001

    Report

    Report Number
    2020394-2001-00010
    Event Type
    Injury
    Date Received
    March 21, 2001
    Date of Event
    January 25, 2001
    Report Date
    February 2, 2001
    Manufacturer
    INTRAVASCULAR, SAS
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PT RETURNED TO THE VASCULAR CLINIC COMPLAINING OF LEFT LEG PAIN. THE PT WAS FOUND TO HAVE AN OCCLUDED LEFT LIMB OF GRAFT UP TO THE BIFURCATION AND WAS RETURNED TO THE O.R. WHERE A THROMBECTOMY WAS PERFORMED USING A FOGARTY GRAFT THROMBECTOMY CATHETER. THE SURGEON FELT THAT THE BLOOD FLOW WAS STILL NOT "NORMAL" AFTER THE THROMECTOMY. THE PT WAS THEN SENT TO INTERVENTIONAL RADIOLOGY, WHERE AN ANGIOGRAM REVEALED A "FILLING DEFECT" IN AN AREA OF THE LEFT LIMB, WHERE A FOGARTY VASCULAR CLAMP WITH SLEEVE WAS ATTACHED TO THE GRAFT DURING THE SURGICAL PROCEDURE. A BALLOON ANGIOPLASTY WAS PERFORMED IN THIS AREA AND WAS FOLLOWED BY A STENT AT ORIGIN OF THE BIFURCATION. THE PT IS NOW O.K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12382 IGK1608-IGK 1608 INTERGARD KNITTED GRAFT 301037753-COATED KNITTED VASCULAR GRAFT MIH INTRAVASCULAR, SAS * 00E12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention