BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2143457 · Received June 29, 2011

    Report

    Report Number
    2134265-2011-02597
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH THROMBOSIS AND EXPERIENCED A STROKE. THE PATIENT PRESENTED DUE TO AN EMERGENT MI AND A 3.5X28MM VERIFLEX STENT WAS PLACED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE STENT WAS WELL POSITIONED AND WELL APPOSED AND THE PATIENT WAS PLACED ON A PLAVIX AND ASPIRIN REGIMENT. TWO DAYS POST THE INDEX PROCEDURE, WHILE STILL IN THE HOSPITAL, THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN AND THROMBOSIS WITHIN THE VERIFLEX STENT. TREATMENT CONSISTED OF A THROMBETCOMY AND ANGIOPLASTY USING A NON CONFORMING 4.0X15 QUANTUM BALLOON. TWO DAYS LATER WHILE STILL IN THE HOSPITAL, THE PATIENT HAD A STROKE. THE PATIENT WAS TRANSFERRED TO A NEARBY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893428350

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention