BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3934701 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04028
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 CATHETER REMOVAL DIFFICULTIES OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PERINEAL ARTERY. A 3.00X38MM PROMUS PREMIER¿ STENT DELIVERY SYSTEM (SDS) WAS SELECTED TO TREAT THE LESION. THE SDS WAS ADVANCED OVER A V14 GUIDE WIRE; HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SDS TOO FAR FORWARD AS IT BECAME ¿STUCK¿ TO THE WIRE. THE PHYSICIAN WET THE PROMUS PREMIER¿ CATHETER DOWN, PULLED AND FINALLY PEELED BACK THE SDS FROM THE GUIDE WIRE. THE PROMUS PREMIER¿ SDS WAS REMOVED WHILE THE V14 REMAINED IN PLACE. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF ANOTHER 3.00X38MM PROMUS PREMIER¿ STENT AND THE SAME V14 GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414270 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952838300 16634626

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR