BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3771385 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02112
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 31, 2014
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE AND OUTER WERE BOTH KINKED AT VARIOUS POSITIONS ALONG THEIR LENGTH THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE STENT WAS DAMAGED AT THE DISTAL END. STRUTS ON THE MOST DISTAL ROWS WERE LIFTED UPWARDS. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE TIP WAS SLIGHTLY FLARED. THIS TYPE OF DAMAGE IS CONSISTENT WITH MEETING AN OBSTRUCTION DURING AN ATTEMPT TO CROSS A LESION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED.   THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS UNSPECIFIED VESSEL. A 2.75X16MM PROMUS ELEMENT PLUS STENT WAS ADVANCED TO TREAT THE LESION BUT WAS UNABLE TO CROSS THE LESION AND THE SHAFT GOT KINKED. THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD . HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249166 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416270 15988441

    Patients

    Seq Age Sex Outcome Treatment
    1