BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3000143 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01394
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED A HYPOTUBE BREAK LOCATED APPROXIMATELY 220MM DISTAL FROM THE CATHETERS STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE BALLOON PROFILE, AND STENT FOUND NO EVIDENCE OF DAMAGE PRESENT. NO FURTHER DAMAGE WAS NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 13. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED AND THEN A 2.75X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104006 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312270 14985027

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR