BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1990056 · Received February 10, 2011

    Report

    Report Number
    2953200-2011-00342
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: HISTORY OF ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, HYPERTENSION AND CEREBROVASCULAR DISEASE. CEREBROVASCULAR ACCIDENT, DEATH, ARRYTHMIAS, SHORT TERM HEMODYNAMIC DETERIORATION, VENTRICULAR FIBRILLATION, MI. DEVICE USED 8 MONTHS POST EXPIRATION DATE. EVALUATION CONCLUSIONS: HISTORY OF ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, HYPERTENSION AND CEREBROVASCULAR DISEASE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT FOLLOWING THE BALLOON DILATATION, THE PATIENT HAS HEMODYNAMIC INSTABILITY AND WAS PLACED ON A HEART/LUNG MACHINE WHEN ANGIOGRAPHIC FINDINGS REVEALED A MYOCARDIAL INFARCTION (ST ELEVATION) DUE TO OCCLUSION OF THE RIGHT CORONARY ARTERY (RCA). THE ARTERY WAS RECANALIZED WITH A DRIVER RX BARE METAL STENT. DURING RECANALIZATION, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND WAS SUCCESSFULLY DEFIBRILLATED. THREE DAYS POST IMPLANT, THE PATIENT SUFFERED AN ISCHEMIC STROKE WITH PARTIAL INFARCTION IN THE LEFT HEMISPHERE. PATIENT WAS THEN SUPERVISED IN THE INTENSIVE CARE UNIT. IT IS REPORTED THAT A CARDIAC DEATH OCCURRED THE FOLLOWING DAY. DEATH WAS REPORTED TO BE DUE TO RESPIRATORY FAILURE. AUTOPSY REPORT IS NOT AVAILABLE. CINE IMAGE REVIEW: PROCEDURAL IMAGES SHOW THE DEPLOYMENT OF THE AORTIC VALVE FOLLOWED BY TREATMENT OF THE PROXIMAL RCA THROUGH A CELL OF THE VALVE DEVICE. NO IMAGES OF THE RCA PATENCY PRIOR TO THE VALVE DEPLOYMENT WERE PROVIDED. POST VALVE DEPLOYMENT, OCCLUSION OF THE RCA CAN BE CONFIRMED ON THE IMAGES. THE OCCLUSION OF THE PROXIMAL RCA APPEAR TO HAVE BEEN TREATED WITH BALLOONING AND STENTING OF THE VESSEL. TREATMENT RESULTED IN FULL FLOW BEING RESTORED TO THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR SANTA ROSA NA 0000736309

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H ASPIRIN| DIURETICS| ANTICOAGULANTIA| CLOPIDOGREL| ANTI-ARRHYTHMICS