BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3881730 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03388
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 23, 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). DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS DAMAGED. STENT STRUTS ON THE 6TH AND 7TH ROWS FROM THE PROXIMAL EDGE WAS LIFTED UPWARDS FROM ITS PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND A KINK ON THE HYPOTUBE SHAFT 165MM PROXIMAL FROM THE STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION OF THE MIDSHAFT SECTION FOUND A KINK AT THE PORT BOND LOCATION. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 75% STENOSED, 3.0MM X 30MM TARGET LESION WITH A LESS THAN 45 DEGREE BEND, AND WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PREDILATATION OF AN UNSPECIFIED BALLOON CATHETER, A 3.00X32MM PROMUS ELEMENT ¿ WAS ADVANCED TO TREAT THE LESION BUT IT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN REPLACED IT WITH A NON-BSC STENT BUT STILL WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357333 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332300 16224166

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR