BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2874312 · Received December 14, 2012

    Report

    Report Number
    2134265-2012-07698
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE SHAFT WAS KINKED. INITIAL VISUAL EXAMINATION FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS INTERVALS ALONG ITS ENTIRE LENGTH. BOTH A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES OR DAMAGE PRESENT. 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, A STENT DAMAGE OCCURRED. THE 75% TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY. DURING PREPARATION, THE 3.00MM X 38MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS NOTICED BY THE PHYSICIAN TO BE ROUGH IN THE SURFACE WHEN FLUSHING THE DEVICE AND THERE WAS A KINK ON THE MID PORTION OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION WAS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, A STENT DAMAGE OCCURRED. THE 75% TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY. DURING PREPARATION, THE 3.00MM X 38MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS NOTICED BY THE PHYSICIAN TO BE ROUGH IN THE SURFACE WHEN FLUSHING THE DEVICE AND THERE WAS A KINK ON THE MID PORTION OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION WAS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 15361445

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR