BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2873795 · Received December 14, 2012

    Report

    Report Number
    2134265-2012-08046
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE DISTAL EDGE OF THE STENT WAS SEVERELY DAMAGED, A NUMBER OF STRUTS WERE CONSIDERABLY STRETCHED. THE PROFILE OF THE STENT ALSO APPEARED SLIGHTLY KINKED. MICROSCOPIC EXAMINATION OF THE BALLOON PROFILE FOUND NO EVIDENCE OF DAMAGE PRESENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE 99% STENOSED TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATION WITH A 2.25X15MM APEX BALLOON, A 2.5X16MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT BUT WAS NOT ABLE TO CROSS THE LESION. A PARALLEL WIRE TECHNIQUE WAS PERFORMED AND A NO CROSS OCCURRED. UPON REMOVAL OF THE 2.25X15MM PROMUS ELEMENT, IT WAS NOTED THAT THE DISTAL STENT EDGE WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE 99% STENOSED TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATION WITH A 2.25X15MM APEX BALLOON, A 2.5X16MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT BUT WAS NOT ABLE TO CROSS THE LESION. A PARALLEL WIRE TECHNIQUE WAS PERFORMED AND A NO CROSS OCCURRED. UPON REMOVAL OF THE 2.25X15MM PROMUS ELEMENT, IT WAS NOTED THAT THE DISTAL STENT EDGE WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316250 15416368

    Patients

    Seq Age Sex Outcome Treatment
    1