BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3221220 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04910
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 6, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. THE STRUTS ON THE FIRST ROW ON THE DISTAL END OF THE STENT WERE MISALIGNED. THE BALLOON AND THE TIP OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILE 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. 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).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE CATHETER WOULD NOT CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE DISTAL AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN PERFORMED ANGIOPLASTY IN THE DISTAL LAD AND IMPLANTED AN UNSPECIFIED STENT IN THE PROXIMAL LAD. THE PHYSICIAN NOTICED THE DISTAL LAD APPEARED "BLOCKED" LIKELY DUE TO DISTAL LESION RECOIL. THE PHYSICIAN THEN PLANNED TO DEPLOY AN ADDITIONAL STENT IN THE DISTAL LAD. A 2.25 X 24 MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320825 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324220 0015264714

    Patients

    Seq Age Sex Outcome Treatment
    1