BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3813171 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02581
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    February 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE WAS BROKEN 213MM DISTAL TO THE STRAIN RELIEF. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE TIP WAS SLIGHTLY FLARED. THIS TYPE OF DAMAGE IS CONSISTENT WITH MEETING AN OBSTRUCTION DURING AN ATTEMPT TO CROSS A LESION. NO ISSUES WERE NOTED WITH THE CRIMPED STENT AND BALLOON. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE. 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 DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED WITH A MAVERICK 2.0X20 CATHETER BALLOON. A 2.50X38MM PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION BUT IT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291311 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438250 16171554

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR CATHETER BALLOON: MAVERICK 2..0X20