BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRITY RX

    MDR report key: 3121941 · Received May 21, 2013

    Report

    Report Number
    9612164-2013-00555
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED); INHERENT RISK OF PROCEDURE (DEATH); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). CONCLUSIONS: UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED); KNOWN INHERENT RISK OF PROCEDURE (DEATH).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS ONLY 1 INTEGRITY BARE METAL STENT IMPLANTED POST THE DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO IMPLANT AN INTEGRITY BARE METAL STENT IN THE CIRCUMFLEX WHICH WAS REPORTED TO BE CALCIFIED WITH 90% STENOSIS AND MODERATE TORTUOSITY. ROTABLATION AND PRE-DILATION WAS CARRIED OUT ON THE LESION. NO ABNORMALITIES WERE NOTED DURING PREPARATION OF THE DEVICE. AS AN ATTEMPT WAS MADE TO PASS THE DEVICE THROUGH THE GUIDE CATHETER, A DEVICE DETACHMENT OCCURRED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE GUIDE CATHETER. TWO INTEGRITY STENTS WERE SUCCESSFULLY DEPLOYED DURING THE PROCEDURE. THE PATIENT SUFFERED LOW BLOOD PRESSURE AND DIED FOUR DAYS LATER. THE PATIENT DEATH WAS ATTRIBUTED TO THEIR MULTIPLE CO-MORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224907 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0006614548

    Patients

    Seq Age Sex Outcome Treatment
    1 Death