BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1181131 · Received September 30, 2008

    Report

    Report Number
    2134265-2008-02841
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE PATIENT WAS ADMITTED DUE TO AN ACUTE NON-ST ELEVATION MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED A SUBTOTAL PROXIMAL LEFT ANTERIOR DESCENDING (LAD) OCCLUSION, A SUBTOTAL OSTIAL SEPTAL PERFORATION OCCLUSION AND HIGH GRADE DISEASE IN THE MID RAMUS AND LEFT CIRCUMFLEX (CX) ARTERIES. THE PATIENT WAS REFUSED SURGERY DUE TO INCREASED RISKS ASSOCIATED WITH CHRONIC KIDNEY DISEASE AND AN ONGOING FOOT INFECTION. THE PHYSICIAN USED A 3.0MM BALLOON, UNKNOWN TYPE, TO PREDILATE THE MID CX. MULTIPLE ATTEMPTS WERE MADE TO PLACE A 3.5X15MM NON BSC STENT TO THE MID CX, BUT THE STENT EVENTUALLY DISLODGED. ATTEMPTS TO RETRIEVE THE STENT WITH A SNARE WERE UNSUCCESSFUL. THE PHYSICIAN USED A 1.5MM BALLOON AND ADVANCED IT THROUGH THE STENT, OPENED IT AND WAS ABLE TO PULL THE STENT BACK TO THE HUB OF THE GUIDE CATHETER AND REMOVE IT FROM THE BODY. THE PHYSICIAN THEN ATTEMPTED TO TREAT THE MID CX WITH A LIBERTE' 3.5X12MM BARE METAL STENT, BUT WAS UNABLE TO ADVANCE IT TO THE LESION DESPITE SEVERAL PREDILATATIONS. THE LIBERTE' STENT THEN DISLODGED IN THE OSTIAL LEFT CX. ATTEMPTS TO RETRIEVE THIS STENT WITH A SNARE WERE UNSUCCESSFUL. A 4.0MM BALLOON WAS THEN ADVANCED TO THE STENT AND THE STENT WAS DEPLOYED AT NOMINAL PRESSURE IN THE OSTIAL LCX AND DISTAL LEFT MAIN ARTERIES. FENTANYL AND VERSED WERE ADMINISTERED DURING THIS PROCEDURE. NO ADDITIONAL PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS STABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DRIVER STENT