BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2153710 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02568
    Event Type
    Death
    Date Received
    July 7, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO A ROTATIONAL ATHERECTOMY AND STENTING PROCEDURE A VESSEL PERFORATION, CARDIAC TAMPONADE AND A DEATH OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ROTABLATOR BURR WAS ADVANCED VIA THE ROTAWIRE GUIDE WIRE TO THE LAD AND ROTATIONAL ATHERECTOMY WAS PERFORMED. THE NUMBER OF ABLATION RUNS IS UNKNOWN HOWEVER SLOW FLOW WAS NOTED. TWO PROMUS STENTS OF AN UNKNOWN SIZE WERE THEN ADVANCED TO THE LESION AND DEPLOYED. ANGIOGRAPHY WAS PERFORMED OF THE TREATED VESSEL AND A PERFORATION WAS NOTICED. IT WAS NOT KNOWN WHAT CAUSED OR WHEN IN THE PROCEDURE THE PERFORATION OCCURRED. A 3.0X19MM NON-BSC STENT WAS ADVANCED TO TREAT THE PERFORATION AND WHEN IT REACHED THE LESION LOCATION THE STENT DISLODGED OFF OF THE BALLOON. AN UNSPECIFIED BALLOON CATHETER WAS THEN ADVANCED TO THE MID LAD AND WAS USED TO IMPLANT THE 3.0X19MM NON-BSC STENT IN THE DISLODGED LOCATION. A SECOND 3.5X19MM NON-BSC STENT WAS THEN ADVANCED TO THE PERFORATION SITE BUT COULD NOT CROSS THE PREVIOUSLY IMPLANTED 3.0X19MM STENT. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS REPORTED AS BEING OK FOLLOWING THIS PROCEDURE, HOWEVER 3 DAYS LATER THE PATIENT EXPIRED. THERE WAS NO ADDITIONAL INTERVENTION BETWEEN THE INITIAL PROCEDURE AND THE PATIENT EXPIRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO A ROTATIONAL ATHERECTOMY AND STENTING PROCEDURE A VESSEL PERFORATION, CARDIAC TAMPONADE AND A DEATH OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ROTABLATOR BURR WAS ADVANCED VIA THE ROTAWIRE GUIDE WIRE TO THE LAD AND ROTATIONAL ATHERECTOMY WAS PERFORMED. THE NUMBER OF ABLATION RUNS IS UNKNOWN HOWEVER SLOW FLOW WAS NOTED. TWO PROMUS STENTS OF AN UNKNOWN SIZE WERE THEN ADVANCED TO THE LESION AND DEPLOYED. ANGIOGRAPHY WAS PERFORMED OF THE TREATED VESSEL AND A PERFORATION WAS NOTICED. IT WAS NOT KNOWN WHAT CAUSED OR WHEN IN THE PROCEDURE THE PERFORATION OCCURRED. A 3.0X19MM NON-BSC STENT WAS ADVANCED TO TREAT THE PERFORATION AND WHEN IT REACHED THE LESION LOCATION THE STENT DISLODGED OFF OF THE BALLOON. AN UNSPECIFIED BALLOON CATHETER WAS THEN ADVANCED TO THE MID LAD AND WAS USED TO IMPLANT THE 3.0X19MM NON-BSC STENT IN THE DISLODGED LOCATION. A SECOND 3.5X19MM NON-BSC STENT WAS THEN ADVANCED TO THE PERFORATION SITE BUT COULD NOT CROSS THE PREVIOUSLY IMPLANTED 3.0X19MM STENT. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS REPORTED AS BEING OK FOLLOWING THIS PROCEDURE, HOWEVER 3 DAYS LATER THE PATIENT EXPIRED. THERE WAS NO ADDITIONAL INTERVENTION BETWEEN THE INITIAL PROCEDURE AND THE PATIENT EXPIRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 3.5X19MM GRAFTMASTER STENT DELIVERY SYSTEM| 3.0X19MM GRAFTMASTER STENT DELIVERY SYSTEM| 2X PROMUS STENTS