BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2162749 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02722
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 3.0-3.5X 45-50MM IN DIAMETER ECCENTRIC LESION BEING TREATED CONTAINED A <45 DEGREE BEND AND WAS LOCATED IN THE MILDLY TORTUOUS, SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH AND UNKNOWN BALLOON. ROTABLATION PERFORMED IN THE PROXIMAL TO MID LAD. THE ROTA WIRE WAS LEFT IN THE LAD AND A NON-BSC GUIDE WIRE WAS ADDED TO THE LAD TO PROVIDE SUPPORT. THE LESION WAS PREDILATED WITH AND UNKNOWN BALLOON. A 3.0X32MM PROMUS ELEMENT STENT WAS DEPLOYED. A PORTION OF THE PROXIMAL LESION WAS NOT COVERED. A 3.5X12MM PROMUS STENT WAS IMPLANTED PROXIMAL TO THE FIRST STENT, WITH INTENT OF OVERLAPPING THE FIRST STENT. HOWEVER, A SMALL GAP BETWEEN THE STENTS REMAINED. THE ¿JAILED¿ NON-BSC GUIDE WIRE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO PASS A 3.0X21MM NON-BSC BALLOON OVER THE ROTA WIRE INTO THE FIRST STENT, BUT THE BALLOON WOULD NOT PASS. THE PHYSICIAN ATTEMPTED TO PASS MULTIPLE BALLOONS INTO FIRST STENT, BUT THEY WOULD NOT PASS. THE PHYSICIAN ATTEMPTED PLACE 2 DIFFERENT NON-BSC GUIDE WIRES AS BUDDY WIRES BUT EXPERIENCED DIFFICULTY. THE PHYSICIAN CONCLUDED THAT THE PROXIMAL STRUTS OF THE 3.0X32MM STENT HAD BEEN CRUSHED BY THE NON-BSC BALLOON. SEVERAL ATTEMPTS TO RE-WIRE THE VESSEL WERE MADE. THE PATIENT BEGAN TO EXPERIENCE A LOSS OF PRESSURE, MEDICATION WAS GIVEN AND A BALLOON PUMP WAS PLACED. THE ATTEMPTED PLACEMENT OF MULTIPLE BALLOONS (INCLUDING: NON-BSC BALLOONS AND 2 APEX BALLOONS) WERE UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO DILATE THE LESION WITH AN UNKNOWN 1.1MM BALLOON. THEN MULTIPLE BALLOONS (OF INCREASING INCREMENTS) WERE USED TO FURTHER DILATE 3.0X32MM STENT. THE FINAL INFLATIONS WERE MADE WITH A 3.0X20MM APEX BALLOON. TWO IVUS RUNS IDENTIFIED A SMALL GAP BETWEEN THE FIRST AND SECOND STENT AND THE VESSEL WAS FOUND TO BE VERY ECCENTRIC AND CALCIFIED. A 4MM PROMUS ELEMENT STENT WAS IMPLANTED COVERING THE GAP BETWEEN THE 2 PLACED STENTS. PATIENT LEFT THE LAB IN A STABLE CONDITION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332300 14134355

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention GALEO GUIDE WIRE| ROTA WIRE