BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1101696 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02234
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS #2134265-2008-02235. IT WAS REPORTED THAT 450 DAYS AFTER CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE PATIENT PRESENTED FOR TREATMENT OF THE INDEX PROCEDURE WITH AN ACUTE MYOCARDIAL INFARCTION. THE TARGET LESION WAS A 3.5MM, 80% STENOSED, 30MM LONG, MODERATELY CALCIFIED, SEVERELY TORTUOUS PORTION OF THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA). THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF TWO EXPRESS2 (3.0X24MM AND 3.5X12MM) STUDY STENTS OVERLAPPING EACH OTHER. SECOND STENT IS PROXIMAL TO THE FIRST. 450 DAYS AFTER THE INDEX PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN WITH HYPOTENSION AND EXPERIENCED AN MI. IT IS UNKNOWN HOW THIS EVENT WAS RESOLVED. PATIENT CONDITION IS LISTED AS O.K. WITH NO COMPLICATIONS NOTED. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE MI TO THE STENTS IS PROBABLY RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O