BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1981168 · Received February 8, 2011

    Report

    Report Number
    2134265-2011-00175
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT (UNIT): LESS THAN (B)(6). THE UNIT WAS NOT RETURNED BY THE CUSTOMER; THEREFORE, NO PRODUCT ANALYSIS COULD BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2011-00174 & 2134265-2011-00173. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, PATIENT COMPLICATIONS AND A DEATH OCCURRED. THE PATIENT PRESENTED EXTREMELY ILL, WEAK AND WITH A POOR PROGNOSIS. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE 85-90% STENOSED DE NOVO AND CONCENTRIC LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX ARTERY (LCX). THE LESION WAS APPROXIMATELY 15-20MM IN LENGTH. INITIALLY, THE PHYSICIAN USED THE 1.5MM ROTALINK BURR AND COMPLETED 3 ABLATION RUNS AT APPROXIMATELY 160K RPMS. THE PHYSICIAN THEN UPSIZED TO THE 1.75MM ROTALINK BURR, HOWEVER ON THE FIRST ABLATION RUN THE PATIENT EXPERIENCED NO FLOW AND CODED. CPR WAS PERFORMED, AND A NON-BSC LEFT VENTRICULAR ASSIST DEVICE WAS INSERTED. NICARDIPINE WAS GIVEN. A GUIDE WIRE WAS ADVANCED AND A BALLOON WAS USED TO REESTABLISH FLOW. THE PATIENT THEN STABILIZED. THE PROCEDURE CONTINUED FOR APPROXIMATELY 1 HOUR AND 45 MINUTES WITH ANGIOPLASTY AND STENT DEPLOYMENT. POST PROCEDURE THE PATIENT'S CONDITION WENT "DOWNHILL" AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA H802228240020

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death ROTALINK ADVANCER| ROTALINK BURR 1.75MM| ROTALINK BURR 1.5MM| CORDIS 8FR XB 3.5 WITH SIDEHOLES CATHETER