BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1953006 · Received January 7, 2011

    Report

    Report Number
    2134265-2010-05846
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 FURTHER REPORTED THAT IN (B)(6) 2005, THE PATIENT PRESENTED WITH A ST ELEVATION MYOCARDIAL INFARCTION. THE 100% STENOSED, 4.5X20MM LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS, SEVERELY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNSPECIFIED 3X20 BALLOON, INFLATED TO 16ATM FOR 30 SECONDS. A 4.50X28MM LIBERTE STENT WAS IMPLANTED, INFLATED TO 14ATM. THE STENT WAS WELL APPOSED. MEDICATIONS GIVEN INCLUDED: CLOPIDOGREL, HEPARIN, AND PLAVIX. IN (B)(6) 2010, ANGIOGRAPHY IDENTIFIED IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED 4.50X28MM LIBERTE STENT. ANTIPLATELET THERAPY AT THE TIME OF THE EVENT WAS ASPIRIN.

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2010-05847. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS OCCURRED. THE LESION BEING TREATED WAS LOCATED DISTAL RIGHT CORONARY ARTERY (RCA). A 4.50X28MM LIBERTE STENT WAS IMPLANTED ON AN UNKNOWN DATE . IN (B)(6) 2010, THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. IN-STENT RESTENOSIS OF THE PREVIOUS PLACED 4.50X28MM LIBERTE STENT WAS IDENTIFIED. THE 100% IN-STENT RESTENOSED, CONCENTRIC, 5X15MM, <= 45 DEGREE BEND LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS, SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH 3 MAVERICK BALLOONS (2.5X15MM, 3.0X15MM, 3.5X15MM). THE PHYSICIAN ATTEMPTED TO PLACE THE 4.50X32MM LIBERTE STENT, BUT WAS UNABLE TO CROSS THE LESION. DURING WITHDRAWAL, THE PHYSICIAN IDENTIFIED THE 4.50X32MM STENT WAS NO LONGER MOUNTED ON THE BALLOON. THE PHYSICIAN ATTEMPTED TO LOCATE THE STENT, BUT WAS UNSUCCESSFUL. ALL OTHER DEVICES WERE REMOVED AND THE STENT WAS NOT FOUND IN THE GUIDE CATHETER. WHILE INTRODUCING ANOTHER GUIDE CATHETER THE STENT WAS LOCATED IN THE RIGHT ARTERY AND HAD PARTIALLY ENTERED INTO THE GUIDE CATHETER. A BALLOON, INFLATED AT LOW ATMS, WAS USED TO TRAP THE STENT AGAINST THE GUIDE CATHETER AND AGAIN ALL OF THE DEVICES WERE REMOVED SIMULTANEOUSLY. FURTHER BALLOON DILATATIONS WERE MADE. THE PROCEDURE WAS COMPLETED WITH DEPLOYMENT OF 3 LIBERTE STENTS (4.5X16MM; 5.0X32MM; 5.0X16MM). THE LESION WAS POST DILATED WITH A 5X15MM MAVERICK BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893828450

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention