BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2901937 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08155
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    September 25, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - INITIAL VISUAL EXAMINATION IDENTIFIED A SHAFT KINK LOCATED APPROXIMATELY 715MM DISTAL FROM THE CATHETERS' STRAIN RELIEF. ALSO SLIGHT KINKING WAS ALSO NOTED AT VARIOUS INTERVALS ALONG THE REMAINDER OF THE HYPOTUBE. FURTHER EXAMINATION OF THE DEVICE FOUND THE STENT WAS ALSO SEVERELY DAMAGED AT ITS DISTAL EDGE. THE STENT HAD BEEN STRETCHED AND A NUMBER OF STRUTS WERE BENT BACK PROXIMALLY AT ITS DISTAL EDGE. THIS TYPE OF DAMAGE IS CONSISTENT WITH SOME FROM OF RESTRICTION HAVING OCCURRED. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(4) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, THE DEVICE WAS UNABLE TO CROSS THE LESION. VASCULAR ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE 95% STENOSED, PROGRESSIVE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED AND THE 3.0X28MM PROMUS ELEMENT STENT WAS ADVANCED, HOWEVER, FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER 3.0X28MM PROMUS ELEMENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8628 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 0014990004

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR GUIDE WIRE: BMW 0.014'' 190