BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1153347 · Received September 5, 2008

    Report

    Report Number
    2134265-2008-02547
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2008-02548. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE PT PRESENTED TO THE ER WITH AN ACUTE ANTERIOR MI AND WAS BROUGHT EMERGENTLY TO THE CARDIAC CATH LAB IN ACUTE RESPIRATORY FAILURE INTUBATED AND ON A VENT. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY AND TWO LESIONS WERE IDENTIFIED. A 100% STENOSED LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 90% STENOSED LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESIONS WERE POST DILATED WITH A 2.5X20MM MAVERICK BALLOON. A 3.0X28MM LIBERTE' STENT WAS PLACED IN THE LAD AND A 2.75X12MM LIBERTE' STENT WAS PLACED IN THE RCA AND TIMI 3 FLOW WS ESTABLISHED. THE STENTS WERE WELL POSITIONED AND APPOSED. THERE WAS NO EVIDENCE OF A DISSECTION. AN INTRA-AORTIC BALLOON PUMP WAS ALSO PLACED AND THE PT WAS TRANSFERRED TO THE CCU. THE PT RECEIVED HEPARIN DURING THE PROCEDURE AND POST PROCEDURE, ASPIRIN, HEPARIN AND PLAVIX WERE ADMINISTERED. EIGHT DAYS LATER THE PT RETURNED TO THE ER IN RESPIRATORY FAILURE AND ANOTHER ANTERIOR MI WITH ST ELEVATIONS. THE PT RETURNED EMERGENTLY TO THE CCL WHERE A THROMBOTIC LESION WAS LOCATED IN THE MID LAD WITH TIMI 2 FLOW DISTALLY. A 3.0X20MM MAVERICK BALLOON WAS ADVANCED ACROSS THE THROMBOTIC LESION AND INFLATED TO 20 ATM'S FOR 20 SECONDS. POST PTCA ANGIO SHOWED EXCELLENT RESULTS. ATTENTION WAS THEN DIRECTED TO THE RIGHT CORONARY SYSTEM WHERE A SEVERE THROMBOTIC LESION WAS FOUND IN THE PROXIMAL RCA WITH TIMI 3 FLOW DISTALLY. THE LESION WAS WIRED AND A 2.5X15MM MAVERICK BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 22 ATM'S. POST PTCA ANGIO SHOWED EXCELLENT RESULTS. THE PT RECEIVED REOPRO DURING THE PROCEDURE. THE PT WAS THEN RETURNED TO CCU FOR FURTHER CARE WITH DISTAL PULSES INTACT. THE PT WAS TO RECEIVE ASPIRIN INDEFINITELY AND PLAVIX FOR A MINIMUM OF ONE YEAR. THE PHYSICIAN ALSO RECOMMENDED AGGRESSIVE CONGESTIVE HEART FAILURE TREATMENT. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 9730686

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention