BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3002387 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01404
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 18, 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. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RECEIVED FOR ANALYSIS. INITIAL VISUAL EXAMINATION IDENTIFIED SEVERE STENT STRUT DAMAGE. AN EXAMINATION OF THE RETURNED STENT FOUND THAT APPROXIMATELY 12MM OF THE MID SECTION OF THE STENT WAS SEVERELY STRETCHED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO FURTHER DAMAGE WAS NOTED ON THE RETURNED 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A STENT STRETCH OCCURRED. THE 99% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 2.25X24MM PROMUS ELEMENT PLUS STENT WAS ADVANCED TO THE LESION AND ENCOUNTERED RESISTANCE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE STENT WAS STRETCHED ON THE BALLOON OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A STENT STRETCH OCCURRED. THE 99% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 2.25X24MM PROMUS ELEMENT PLUS STENT WAS ADVANCED TO THE LESION AND ENCOUNTERED RESISTANCE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE STENT WAS STRETCHED ON THE BALLOON OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104905 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424220 15367266

    Patients

    Seq Age Sex Outcome Treatment
    1