BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ? LONG

    MDR report key: 3781582 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02275
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS NOT DAMAGED AND EXHIBITED NO SIGNS OF ATTEMPTS OF DEPLOYMENT. THE BALLOON CONES PROFILES WERE ALSO REVIEWED AND NO ISSUES WERE NOTED THE OVERALL BALLOON PROFILE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE MIDSHAFT SECTION FOUND KINKS ADJACENT TO THE PORT BOND LOCATION. THE COMPLAINT REPORT NOTED THAT THE DEVICE SHAFT WAS FRACTURED, HOWEVER THE EXAMINATION FOUND SEVERE KINKS AND NO EVIDENCE OF FRACTURE OR BREAKAGE. A VISUAL AND TACTILE EXAMINATION FOUND A SEVERE KINK ON THE HYPO-TUBE SHAFT AT THE PROXIMAL END WITHIN THE MANIFOLDS¿ STRAIN RELIEF SECTION. 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 SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 85% STENOSED, 16X3.5MM, DE NOVO TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS NOT PERFORMED. A 3.50X38MM PROMUS ELEMENT LONG DRUG-ELUTING STENT WAS SELECTED TO TREAT THE TARGET LESION. UPON ADVANCING, IT WAS NOTICED THAT THE SHAFT OF STENT DELIVERY SYSTEM AT THE RX EXIT PORT WAS FRACTURED AT THE OSTIUM OF THE UNSPECIFIED MONORAIL GUIDE WIRE(WHICH LOCATION IS EXCHANGED GUIDEWIRE) THUS, THE STENT COULD NOT BE DEPLOYED. THE PHYSICIAN WITHDREW THE DEVICE AND WAS RETRIEVED INTACT. THE PROCEDURE WAS COMPETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 85% STENOSED, 16X3.5MM, DE NOVO TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS NOT PERFORMED. A 3.50X38MM PROMUS ELEMENT ¿ LONG DRUG-ELUTING STENT WAS SELECTED TO TREAT THE TARGET LESION. UPON ADVANCING, IT WAS NOTICED THAT THE SHAFT OF STENT DELIVERY SYSTEM AT THE RX EXIT PORT WAS FRACTURED AT THE OSTIUM OF THE UNSPECIFIED MONORAIL GUIDE WIRE(WHICH LOCATION IS EXCHANGED GUIDEWIRE) THUS, THE STENT COULD NOT BE DEPLOYED. THE PHYSICIAN WITHDREW THE DEVICE AND WAS RETRIEVED INTACT. THE PROCEDURE WAS COMPETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260447 PROMUS ELEMENT ? LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338350 0016269727

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR