BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3243439 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04895
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED PROXIMAL STENT DAMAGE. STRUTS AT THE PROXIMAL EDGE WERE RAISED AND MISALIGNED. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. 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 THE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT WAS UNABLE TO CROSS THE LESION. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE ECCENTRIC, DE NOVO, 95% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN PREDILATED HE TARGET LESSON WITH A 1.5MM MAVERICK BALLOON AND THEN ADVANCED A 2.75X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION. THE SDS WAS UNABLE TO CROSS THE LESION AND WAS SUCCESSFULLY REMOVED. THEN THE PHYSICIAN INFLATED A 2.0 BALLOON CATHETER IN THE TARGET LESION, HOWEVER THE PATIENT BECAME UNSTABLE AND THE PROCEDURE WAS DISCONTINUED. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT AND DIED THE FOLLOWING DAY. PHYSICIAN¿S ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE IS ¿UNLIKELY TO BE RELATED¿. AND THAT OTHER POSSIBLE CONTRIBUTING FACTORS TO THE EVENT ARE ¿PROCEDURE¿ AND ¿CO-MORBIDITY¿. RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343359 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 15668287

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR