BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 2863317 · Received December 10, 2012

    Report

    Report Number
    9612164-2012-01757
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS- LESION NOT PRE-DILATED AND FORCE APPLIED WHEN RESISTANCE MET. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE -CALCIFIED. INHERENT RISK OF PROCEDURE-STENT DEFORMATION AND FAILURE TO DELIVER THE STENT. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-STENT DEFORMATION AND FAILURE TO DELIVER THE STENT. UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-CALCIFIED. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT AN INTEGRITY RX BARE METAL STENT .THE LESION HAD NOT BEEN PRE-DILATED. DURING ATTEMPTED DELIVERY, THE DEVICE COULD NOT CROSS UNANTICIPATED CALCIUM EVEN THOUGH THE PHYSICIAN PUSHED HARD. WHEN THE DEVICE WAS REMOVED, STENT DAMAGE WAS NOTED. THE LESION WAS SUBSEQUENTLY PER-DILATED AND ANOTHER STENT WAS USED. NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0006024395

    Patients

    Seq Age Sex Outcome Treatment
    1