BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2982708 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01137
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    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 COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE DILATION WITH A NON BSC BALLOON CATHETER, AN UNSPECIFIED IVUS CATHETER WAS USED TO DIAGNOSE THE TARGET LESION. THE 2.75 X 20MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS ADVANCED THROUGH A 6FR. MACH 1 GUIDE CATHETER OVER A NON BSC GUIDE WIRE, BUT WAS UNABLE TO CROSS THE LESION. WHEN THE SDS WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88578 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 15668287

    Patients

    Seq Age Sex Outcome Treatment
    1 RAIDEN: BALLOON CATHETER| 6FR MACH1: GUIDE CATHETER| SION: GUIDE WIRE