BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2153054 · Received June 28, 2011

    Report

    Report Number
    9612164-2011-00645
    Event Type
    Death
    Date Received
    June 28, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: DISSECTION DUE TO THE GUIDE CATHETER. CONCLUSION: DISSECTION DUE TO THE GUIDE CATHETER.

    Description of Event or Problem · 1

    ONE ENDEAVOR RAPID EXCHANGE DRUG ELUTING STENT WAS DEPLOYED AT THE PROXIMAL SIDE OF THE MID LAD, OVERLAPPING A NON-MEDTRONIC STENT PLACED IN THE MID AND DISTAL LAD. POST DEPLOYMENT OF THE STENTS, THE PHYSICIAN ADVANCED THE IVUS DEVICE WITHOUT ANY DIFFICULTY AND CONFIRMED THAT THE TWO STENTS WERE NOT FULLY EXPANDED. ON ATTEMPTED REMOVAL OF THE IVUS, THE PHYSICIAN FOUND THAT IT WAS STUCK IN THE OVERLAPPED SECTION OF TWO STENTS. WHILE ATTEMPTING TO REMOVE IT, A DISSECTION WAS OBSERVED AT LEFT MAIN TRUNK WHICH WAS REPORTED TO HAVE OCCURRED DUE TO THE GUIDE CATHETER. THE PT'S BLOOD PRESSURE DECREASED, VENTRICULAR TACHYCARDIA / VENTRICULAR FIBRILLATION WERE OBSERVED AND A DIRECT-CURRENT DEFIBRILLATOR WAS USED. CARDIAC MASSAGE WAS PERFORMED AND AN INTRA AORTIC BALLOON PUMP WAS INSERTED FROM THE FEMORAL ARTERY. PHYSICIAN THEN ADVANCED A 7F GUIDE CATHETER, BUT FAILED AS HE COULD NOT ADVANCE THE RUNTHROUGH GUIDEWIRE DUE TO THE DISSECTION. PHYSICIAN THEN DILATED THE LESION USING THE ENDEAVOR STENT DELIVERY SYSTEM AND SUCCESSFULLY REMOVED THE IVUS. DESPITE ASPIRATION OF THE LESION AND MULTIPLE DILATIONS, THE BLOOD FLOW FROM THE LAD TO THE LCX WAS POOR AND THE PT DIED. THE PHYSICIAN COMMENTED THAT THE PT'S DEATH RESULTED FROM THE DISSECTION DUE TO THE GUIDE CATHETER AND THE SUBSEQUENT INTERRUPTION OF BLOOD FLOW FROM THE LAD TO THE LCX. REFERENCE MFR REPORT # 1220452-2011-00047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death