BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3890360 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03964
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE CRIMPED STENT WAS DETACHED FROM BALLOON AND NOT RETURNED WITH DEVICE FOR ANALYSIS. A MICROSCOPIC EXAMINATION OF THE BALLOON FOUND THAT CRIMP MARKINGS WERE EVIDENT ON THE WALL OF THE BALLOON AS WOULD BE EXPECTED. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE OF THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS FIRST ABLATED USING A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM AND DILATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. THEN THE 12MM X 2.25MM PROMUS PREMIER STENT WAS ADVANCED IN THE MID LAD BUT WAS NOT ABLE TO CROSS THE LESION AFTER SEVERAL ATTEMPTS. THE DEVICE WAS REMOVED FROM THE BODY AND IT WAS FOUND OUT THAT THE DISTAL PORTION OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED USING A 2.25MM X 16MM PROMUS PREMIER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS FIRST ABLATED USING A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM AND DILATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. THEN THE 12MM X 2.25MM PROMUS PREMIER¿ STENT WAS ADVANCED IN THE MID LAD BUT WAS NOT ABLE TO CROSS THE LESION AFTER SEVERAL ATTEMPTS. THE DEVICE WAS REMOVED FROM THE BODY AND IT WAS FOUND OUT THAT THE DISTAL PORTION OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED USING A 2.25MM X 16MM PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367726 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925112220 16730424

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTATIONAL ATHERECTOMY SYSTEM: ROTABLATOR