BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2902161 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08348
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED PROXIMAL STENT DAMAGE. STRUTS AT THE PROXIMAL EDGE WERE RAISED 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. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT WAS DAMAGED. THE MILDLY TORTUOUS AND SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A KINETIX PLUS GUIDE WIRE WAS ADVANCED AND A NON-BSC BALLOON WAS INFLATED FOR PREDILATATION. A 3.00X38MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE DISTAL RCA. A SECOND 3.00X38MM PROMUS ELEMENT STENT WAS TO BE USED TO OVERLAP THE PREVIOUSLY IMPLANTED STENT BUT WAS UNABLE TO CROSS THE PROXIMAL RCA DUE TO HEAVY CALCIFICATION. AFTER REMOVAL IT WAS NOTED THAT THE STENT WAS FLARED. A NON-BSC GUIDE WIRE WAS ADVANCED AND ANOTHER 3.0X38MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE MID RCA AND A 3.5X38MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE PROXIMAL RCA. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT WAS DAMAGED. THE MILDLY TORTUOUS AND SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A KINETIX PLUS GUIDE WIRE WAS ADVANCED AND A NON-BSC BALLOON WAS INFLATED FOR PREDILATATION. A 3.00X38MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE DISTAL RCA. A SECOND 3.00X38MM PROMUS ELEMENT STENT WAS TO BE USED TO OVERLAP THE PREVIOUSLY IMPLANTED STENT BUT WAS UNABLE TO CROSS THE PROXIMAL RCA DUE TO HEAVY CALCIFICATION. AFTER REMOVAL IT WAS NOTED THAT THE STENT WAS FLARED. A NON-BSC GUIDE WIRE WAS ADVANCED AND ANOTHER 3.0X38MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE MID RCA AND A 3.5X38MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE PROXIMAL RCA. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8609 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 0015571090

    Patients

    Seq Age Sex Outcome Treatment
    1 KINETIX PLUS GUIDE WIRE