BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX SONIC STENT DELIVERY SYSTEM (OUS RX)

    MDR report key: 1053622 · Received May 23, 2008

    Report

    Report Number
    9616099-2008-01387
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    March 26, 2007
    Report Date
    April 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCT ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2008-01388. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THIS FEMALE PT WAS ENROLLED IN THE REGISTRY IN 2008. THE PT'S MEDICAL HISTORY INCLUDES PREVIOUS PERCUTANEOUS CORONARY INTERVENTION, HYPERTENSION AND HYPERLIPIDAEMIA. THE MAIN INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE PT HAD TWO CYPHER SELECT PLUS STENTS IMPLANTED; ONE IN THE MID LEFT ANTERIOR DESCENDING AND THE OTHER IN THE PROXIMAL CIRCUMFLEX. THE LESIONS WERE IN-STENT RESTENOSIS OF TWO PREVIOUSLY IMPLANTED BX SONIC STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC STENT DELIVERY SYSTEM (OUS RX) CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R ASPIRIN| CLOPIDOGREL