BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2874592 · Received December 15, 2012

    Report

    Report Number
    2134265-2012-07559
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: INITIAL VISUAL EXAMINATION IDENTIFIED THAT A NUMBER OF PROXIMAL STENT STRUTS HAD BEEN BENT BACK DISTALLY. 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. NO KINKS OR DAMAGE WAS NOTED WITH THE HYPOTUBE/SHAFT. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE OF THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS, NON CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ATTEMPTED TO CROSS THE MID LEFT ANTERIOR DESCENDING ARTERY USING A PROMUS ELEMENT MR-4.00X28MM MONORAIL, BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE DISTAL EDGE WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A BARE METAL STENT FROM ANOTHER MANUFACTURER AS THERE WAS NO OTHER DRUG ELUTING STENT OF THAT SIZE AVAILABLE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS, NON CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ATTEMPTED TO CROSS THE MID LEFT ANTERIOR DESCENDING ARTERY USING A PROMUS ELEMENT MR-4.00X28MM MONORAIL, BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE DISTAL EDGE WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A BARE METAL STENT FROM ANOTHER MANUFACTURER AS THERE WAS NO OTHER DRUG ELUTING STENT OF THAT SIZE AVAILABLE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328400 15214837

    Patients

    Seq Age Sex Outcome Treatment
    1