BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ? LONG

    MDR report key: 3122048 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03430
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: DEVICE WAS RETURNED, A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. STRUT ROWS FROM THE PROXIMAL END OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE GUIDEWIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT DAMAGE OCCURED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL APPROACH. THE 80% STENOSED, 2.5X30MM, ECCENTRIC, DE NOVO LESION WAS LOCATED AT THE MODERATELY CALCIFIED AND MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN INCORPORATED MOTHER AND CHILD TECHNIQUE WITH A 6FR MACH1 AL1 GUIDE CATHETER AND AN UNSPECIFIED ST01 MICROCATHETER. A 2.50X38MM PROMUS ELEMENT LONG DRUG ELUTING STENT WAS ADVANCED BUT THE STENT WAS UNABLE TO PASS THE HEAVILY CALCIFIED MID RCA. THE 2.50X38MM PROMUS ELEMENT WAS WITHDRAWN BUT GOT CAUGHT IN THE MICROCATHETER AND WAS COMPRESSED FOR 2CM. THE ENTIRE SYSTEM WAS REMOVED TO RETRIEVE THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT DAMAGE OCCURED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL APPROACH. THE 80% STENOSED, 2.5X30MM, ECCENTRIC, DE NOVO LESION WAS LOCATED AT THE MODERATELY CALCIFIED AND MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN INCORPORATED MOTHER AND CHILD TECHNIQUE WITH A 6FR MACH1 AL1 GUIDE CATHETER AND AN UNSPECIFIED ST01 MICROCATHETER. A 2.50X38MM PROMUS ELEMENT LONG DRUG ELUTING STENT WAS ADVANCED BUT THE STENT WAS UNABLE TO PASS THE HEAVILY CALCIFIED MID RCA. THE 2.50X38MM PROMUS ELEMENT WAS WITHDRAWN BUT GOT CAUGHT IN THE MICROCATHETER AND WAS COMPRESSED FOR 2CM. THE ENTIRE SYSTEM WAS REMOVED TO RETRIEVE THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224280 PROMUS ELEMENT ? LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338250 15295004

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR