BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURANT COBALT

    MDR report key: 2873370 · Received December 14, 2012

    Report

    Report Number
    9612164-2012-01773
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEFORMATION PROBLEM (LONGITUDINAL TEAR ON THE BALLOON). CONCLUSION: UNABLE TO CONFIRM COMPLAINT (THE DEVICE EVALUATION DID NOT DETECT ANY ISSUE WITH THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE DEFLATION DIFFICULTIES). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN USED AN ASSURANT COBALT OVER THE WIRE (OTW) PERIPHERAL STENT TO TREAT LEFT COMMON ILIAC ARTERY WHICH EXHIBITED 80-90% STENOSIS, MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE PROCEDURE INVOLVED ANGIOPLASTY AND STENTING. THE LESION WAS PRE-DILATED WITH A BALLOON AND THEN THE ASSURANT COBALT STENT PASSED ACROSS LESION. THE DEVICE WAS INFLATED TO NOMINAL PRESSURE. STENT DEPLOYED WITH NO ISSUES REPORTED. POST STENT DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON USING INFLATION DEVICE BUT TO NO AVAIL. NEGATIVE WAS PULLED BACK SEVERAL TIME ON INFLATION DEVICE BUT NOTHING CAME BACK. THE BALLOON WAS THEN INFLATED TO RATED BURST PRESSURE AND ANOTHER ATTEMPT TO DEFLATE BALLOON WAS MADE BUT THIS FAILED. THE PHYSICIAN DECIDED TO TAKE THE BALLOON PAST RATED BURST PRESSURE AT WHICH STAGE THE BALLOON BURST AND THE DELIVERY DEVICE WAS ABLE TO BE REMOVED. IT WAS REPORTED THAT THE PATIENT WAS STAB LE POST PROCEDURE. NO CLINICAL SEQUELAE WERE REPORTED. DEVICE EVALUATION: THE DEVICE WAS RECEIVED FOR EVALUATION. THE STENT HAD BEEN DEPLOYED IN THE PATIENT. THERE WAS A LONGITUDINAL TEAR MEASURING 5.5CM ALONG THE BALLOON WORKING LENGTH. THE DEVICE FAILED NEGATIVE PREP AND DID NOT INFLATE WHEN PRESSURIZED. THE INNER WAS KINKED UNDER THE BALLOON WORKING LENGTH AT 56CM DISTAL TO THE STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND 0005714764

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR