BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2878486 · Received December 18, 2012

    Report

    Report Number
    2134265-2012-08172
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPN CORRECTED FROM (B)(4). CATALOG/MODEL # CORRECTED FROM 39113-2030 TO 39184-2025. DEVICE LOT NUMBER CORRECTED FROM 15213236 TO 15475549. DEVICE EXPIRATION DATE CORRECTED FROM 09/21/2013 TO 01/12/2014. PMA# OR 510K# CORRECTED FROM 'SIMILAR' TO P110010. DEVICE MANUFACTURED DATE CORRECTED FROM (B)(4)2012. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. THE STRUTS ON THE FIRST TWO ROWS ON THE PROXIMAL END OF THE STENT WERE BUNCHED TOGETHER AND RAISED UP. THE BALLOON AND THE TIP OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE 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

    DESCRIBE EVENT OR PROBLEM CORRECTED. (B)(4). CATALOG/MODEL # CORRECTED FROM 39113-2030 TO 39113-2025. DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, AND DEVICE MANUFACTURED DATE WERE INITIALLY REPORTED HOWEVER THIS INFORMATION WAS NOT CORRECT AND IS NOT AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. A 3.00X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS OPENED FOR USE WHEN IT WAS NOTED THAT THE STENT STRUTS ON ONE END APPEARED TO BE RAISED UP FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    THE DEVICE WAS INITIALLY REPORTED AS A 3.00X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED AND THE DEVICE WAS CONFIRMED TO BE A 2.50X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. A 3.00X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS OPENED FOR USE WHEN IT WAS NOTED THAT THE STENT STRUTS ON ONE END APPEARED TO BE RAISED UP FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420250 15475549

    Patients

    Seq Age Sex Outcome Treatment
    1