BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3905126 · Received July 1, 2014

    Report

    Report Number
    2134265-2014-03731
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATION 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 STENT DAMAGE AND MOVEMENT ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE DIAGONAL LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 28MM PROMUS PREMIER STENT WAS ADVANCED THROUGH A PREVIOUSLY IMPLANTED UNSPECIFIED "CHRONIC KEY" STENT TOWARDS THE DISTAL PART OF THE LESION HOWEVER THE DEVICE HAD DIFFICULTY PASSING THROUGH THE STENT. THE 2.50MM X 28MM PROMUS PREMIER STENT WAS REMOVED AND IT WAS NOTICED THAT THE STENT HAD UNRAVELED. THE PROXIMAL END OF THE STENT STAYED ON THE BALLOON. THE WHOLE SYSTEM WAS ABLE TO BE REMOVED FROM THE PATIENT WITH THE STENT STILL INTACT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THERE WERE NO ISSUES WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384983 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952828250 16848274

    Patients

    Seq Age Sex Outcome Treatment
    1