BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1781365 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03286
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 DEFLATION DIFFICULTIES AND WITHDRAWAL RESISTANCE OCCURRED. THE 90-99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY AND A MAVERICK BALLOON WAS ADVANCED TO THE LESION FOR PREDILATION. A 3.0X32MM PROMUS ELEMENT STENT WAS THEN ADVANCED TO THE LAD AND WAS SUCCESSFULLY DEPLOYED AT 16ATMS. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT DELIVERY BALLOON FROM THE DEPLOYED STENT HE EXPERIENCED 'FRICTION' AND IT WAS ALSO NOTED THAT THE BALLOON WAS NOT FULLY DEFLATED. THE STENT DELIVERY SYSTEM (SDS) WAS ABLE TO BE REMOVED FROM THE PATIENT AND THE DEPLOYED PROMUS ELEMENT STENT STAYED WELL POSITIONED AND APPOSED. TWO ADDITIONAL UNSPECIFIED STENTS WERE IMPLANTED IN AN UNSPECIFIED LESION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS STABLE.

    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 13368275

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR LAUNCHER EBU 3.5 GUIDE CATHETER| MAVERICK BALLOON CATHETER| BMW GUIDE WIRE