BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX VELOCITY BILIARY SDS

    MDR report key: 1000037 · Received February 14, 2008

    Report

    Report Number
    1016427-2008-00037
    Event Type
    Injury
    Date Received
    February 14, 2008
    Date of Event
    October 7, 2002
    Report Date
    January 18, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P900043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE BX VELOCITY STENT (COMPLAINT PRODUCT) WAS IMPLANTED DURING THE INDEX PROCEDURE TO TREAT RIGHT CORONARY ARTERY (RCA) TARGET LESION. THE PT REPORTED, HE PREVIOUSLY HAD A GUIDANT STENT IMPLANTED IN THIS VESSEL. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE PT THROUGH THE MEDICAL AFFAIRS DEPARTMENT INDICATED THAT APPROX TWO MONTHS AFTER IMPLANTATION OF A BX VELOCITY 2.5X 13MM STENT WITH HEPACOAT, THE PT HAD CHEST PAIN. THE PT WAS ADMITTED EMERGENTLY TO THE HOSPITAL. CORONARY ANGIOGRAPHY REVEALED A 75% STENOSIS OF THE PREVIOUSLY IMPLANTED STENT. THE RESTENOSIS WAS TREATED NINETEEN DAYS LATER BY IMPLANTATION OF A GUIDANT STENT. ADD'L INFO HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX VELOCITY BILIARY SDS CORONARY SDS/STENTS (MAF) MAF CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R