BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3232567 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04863
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE WAS NOTED. AFTER AN UNSPECIFIED GUIDEWIRE WAS USED TO CROSS THE TARGET LESION, AN ATTEMPT WAS MADE TO DELIVER THE 2.25MM X 16MM PROMUS ELEMENT PLUS STENT HOWEVER, UPON INSERTION OF THE GUIDEWIRE INTO THE DISTAL TIP OF THE STENT DELIVERY SYSTEM (SDS), THE EDGE OF THE STENT WAS NOTICED TO BE "LIFTED". THE DEVICE WAS THEN EXCHANGED WITH ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336228 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416220 15720211

    Patients

    Seq Age Sex Outcome Treatment
    1