BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3111475 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03337
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    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

    DEVICE IS A COMBINATION PRODUCT. PATIENT AGE AT TIME OF EVENT: ABOVE 18 YEARS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: DEVICE WAS RETURNED WITH KINKS ON THE HYPOTUBE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT WAS DAMAGED. THE STENT WAS DAMAGED AND STRETCHED ALONG ITS LENGTH SO THAT THE STENT EXTENDED APPROXIMATELY 2 MM DISTAL TO THE DISTAL END OF THE DISTAL MARKERBAND. 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. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT DAMAGE OCCURED. THE 90% STENOSED LESION WAS LOCATED AT THE SEVERELY TORTUOUS AND CALCIFIED MIDDLE LEFT CIRCUMFLEX ARTERY. AFTER REPEATEDLY CROSSING THE LESION WITH A 2.25X24MM PROMUS ELEMENT PLUS DRUG ELUTING STENT THE DISTAL EDGE WAS FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT DAMAGE OCCURED. THE 90% STENOSED LESION WAS LOCATED AT THE SEVERELY TORTUOUS AND CALCIFIED MIDDLE LEFT CIRCUMFLEX ARTERY. AFTER REPEATEDLY CROSSING THE LESION WITH A 2.25X24MM PROMUS ELEMENT PLUS DRUG ELUTING STENT THE DISTAL EDGE WAS FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213396 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424220 15571181

    Patients

    Seq Age Sex Outcome Treatment
    1