BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2832397 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06915
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    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 THE TIME OF THE EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: INITIAL VISUAL EXAMINATION IDENTIFIED A SHAFT KINK LOCATED APPROXIMATELY 25MM 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 DAMAGED AT ITS DISTAL EDGE, AN INDIVIDUAL STRUT HAD BEEN RAISED. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGED OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.00MM X 20MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION; HOWEVER, THE DEVICE DID NOT CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP OF THE STENT WAS LIFTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY, USING A NON BSC STENT. THE PATIENT'S CURRENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGED OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.00MM X 20MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION; HOWEVER, THE DEVICE DID NOT CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP OF THE STENT WAS LIFTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY, USING A NON BSC STENT. THE PATIENT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 0014952399

    Patients

    Seq Age Sex Outcome Treatment
    1