BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1696788 · Received May 24, 2010

    Report

    Report Number
    2134265-2010-02516
    Event Type
    Death
    Date Received
    May 24, 2010
    Date of Event
    January 18, 2010
    Report Date
    April 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). 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 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 MFR REPORT #: 2134265-2010-02512, 2134265-2010-02513, 2134265-2010-02514, 2134265-2010-02515, 2134265-2010-02517. IT WAS REPORTED THAT DURING AN INTERVENTIONAL CORONARY ROTATIONAL ATHERECTOMY PROCEDURE, TWO WIRES BROKE, REMOVAL DIFFICULTIES OCCURRED, AND PATIENT COMPLICATIONS LEADING TO PATIENT DEATH OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID LEFT CIRCUMFLEX (LCX) ARTERY. THE VESSEL DIAMETER WAS 2.75MM. THE LESION WAS ECCENTRIC AND DE NOVO. FIRST, THE PHYSICIAN ATTEMPTED TO CROSS A 1.5MM ROTALINK PLUS AT 177,000 RPMS, HOWEVER WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO EXCHANGE TO A 1.25MM ROTALINK PLUS BURR, HOWEVER HE ENCOUNTERED HANDSHAKE CONNECTION DIFFICULTIES. THEN, A 1.25MM ROTALINK PLUS BURR WAS ATTEMPTED TO CROSS THE LESION AT 180,000, HOWEVER THIS RESULTED IN A BREAK OF THE DISTAL PORTION OF THE FLOPPY ROTAWIRE. A 1.25X12MM NON-BSC BALLOON WAS ADVANCED AND INFLATED TO 26 ATMS, HOWEVER THIS DID NOT FULLY DILATE THE LESION AND THE BALLOON RUPTURED. A SECOND FLOPPY ROTAWIRE WAS THEN ADVANCED, AND A SECOND 1.25MM ROTALINK PLUS WAS ATTEMPTED TO CROSS THE LESION, HOWEVER THE BURR DID NOT CROSS AND THE WIRE ¿RUPTURED¿. SEVERAL BALLOONS INCLUDING A 1.5MM X 8MM APEX PUSH MONORAIL WERE USED TO DILATE THE LESION WITHOUT SUCCESS. ANOTHER 1.25MM ROTALINK PLUS WAS THEN ADVANCED ON A FLOPPY ROTAWIRE TO THE MID SECTION OF THE LESION, AND THE BURR BECAME STUCK IN THE LESION. A NON-BSC WIRE WAS ADVANCED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY TO ENSURE ACCESS AND WITH STRONG TRACTION THE BURR WAS REMOVED FROM THE LCX. ANGIOGRAPHY SHOWED THE LCX OCCLUDED AND THE LAD WITH ACCEPTABLE DISTAL FLOW. THE PATIENT EXPERIENCED SEVERE HYPOTENSION. THE LESION IN THE LCX WAS THEN DILATED AGAIN WITH MULTIPLE BALLOONS INCLUDING A 1.5 X 8MM APEX PUSH MONORAIL BALLOON. WITH A BUDDY WIRE TECHNIQUE, 2 PROMUS ELEMENT STENTS WERE DEPLOYED, A 2.75X24MM DEPLOYED AT 16 ATMS IN THE DISTAL LCX AND 2.75X20MM IN THE PROXIMAL LCX. ACT RESULTS WERE WITHIN RANGE AND REOPRO WAS ADMINISTERED. HOWEVER, NO REFLOW OCCURRED IN THE LCX WITH FURTHER HEMODYNAMIC COMPROMISE AND PROGRESSIVE SLOW REFLOW IN THE LAD. A DISSECTION OCCURRED DURING THE PROCEDURE BUT IT IS UNKNOWN AT WHAT POINT AND WHAT DEVICE CAUSED THE DISSECTION. SEVERE HYPOTENSION ENSUED WITH SUBSEQUENT VENTRICULAR ARRHYTHMIAS AND CARDIAC ARREST. A PACEMAKER AND INTRA-AORTIC BALLOON PUMP WERE IMPLANTED WITHOUT IMPROVEMENT OF CLINICAL CONDITION, AND DESPITE RESUSCITATION ATTEMPTS, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death MEDTRONIC SPRINTER 1.5 X 12| MEDTRONIC SPRINTER 1.5 X 12| MEDTRONIC SPRINTER 1.5 X 12| ASAHI GRAND SLAM GUIDE WIRE| ABBOTT WHISPER GUIDE WIRE| MEDTRONIC SPRINTER 2 X 15| ABBOTT VOYAGER NC 2.5 X 15