BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003538 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00457
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE DEVICE REVEALED STENT DAMAGE. DAMAGE WAS NOTED IN THE MIDDLE PORTION OF THE STENT, ONE STRUT WAS BENT BACK AND ANOTHER WAS SLIGHTLY OUT OF PLACE. THE STENT WAS ALSO SLIGHTLY BENT ONE ROW OVER FROM WHERE THE STENT STRUTS WERE LIFTED. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED BETWEEN THE MARKERBANDS. MAGNIFIED INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. A 2.75X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PACKAGE AND IT WAS NOTED THAT ONE STENT STRUT WAS NOT CRIMPED PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. A 2.75X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PACKAGE AND IT WAS NOTED THAT ONE STENT STRUT WAS NOT CRIMPED PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911320270 0013930077

    Patients

    Seq Age Sex Outcome Treatment
    1