BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2851649 · Received November 29, 2012

    Report

    Report Number
    2134265-2012-07188
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 7, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A SHAFT HYPOTUBE BREAK LOCATED 24.5CM FROM THE CATHETER STRAIN RELIEF. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE CRIMPED STENT, 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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR#2134265-2012-07189 AND MDR#2134265-2012-07190. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION. THE 60% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS, SEVERELY CALCIFIED 'COMPLEX INTERVENTRICULAR ARTERY'. THREE PROMUS ELEMENT STENTS WERE INTRODUCED BUT WERE UNABLE TO CROSS THE TARGET LESION, A 2.75X20MM PROMUS ELEMENT SDS, A 3.00X32MM SDS, AND A 2.5 X 32MM SDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS ELEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 0015329817

    Patients

    Seq Age Sex Outcome Treatment
    1