BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2925794 · Received January 22, 2013

    Report

    Report Number
    2134265-2013-00394
    Event Type
    Death
    Date Received
    January 22, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-00570 & 2134265-2013-00602. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY AND STENTING TREATMENT PROCEDURE, THE PATIENT DIED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL VEIN. THE 80-95% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED OSTIAL LEFT ANTERIOR DESCENDING ARTERY (LAD) INTO THE LEFT MAIN (LM). THE 1.75MM ROTABLATOR BURR WAS UTILIZED SUCCESSFULLY FOR ABLATION OF THE LESION. THE 3.0X15MM EMERGE BALLOON WAS UTILIZED. AFTER INFLATION OF THE BALLOON, THE PATIENT'S BLOOD PRESSURE DECREASED "IN A QUICK FASHION". A 3.5X16MM NON-BSC BARE METAL STENT WAS DEPLOYED 'QUICKLY' AT 12 ATMS FOR 20 SECONDS. THE BLOOD PRESSURE CONTINUED TO DECLINE INTO THE 60'S DESPITE FLUID BOLUSES AND ONE AMP OF EPINEPHRINE. FLUOROSCOPY REVEALED A PATENT STENT AND PATENT LAD WITH REASONABLE FLOW BUT NO CARDIAC CONTRACTILITY. MULTIPLE ATTEMPTS WERE MADE AT CARDIO-PULMONARY RESUSCITATION WITHOUT SUCCESS. A LEFT-SIDED ARTERIAL ACCESS WAS OBTAINED FOR PLACEMENT OF A BALLOON PUMP, HOWEVER THE PATIENT WAS ALREADY TOO SEVERELY COMPROMISED. ONE SHOCK WAS PERFORMED FOR VENTRICULAR TACHYCARDIA THAT WAS PULSELESS. THE PATIENT WAS DECLARED DEAD IN THE CATH LAB. THE DOCUMENTED CAUSE OF DEATH WAS CARDIAC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30881 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK UNK553

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death