BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERYS YSTEM

    MDR report key: 1040180 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01337
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, DISSECTION OCCURRED AND POST PROCEDURE RESTENOSIS OCCURRED. THE 90% STENOSED, SEVERE AND DIFFUSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PROXIMAL AND DISTAL RIGHT CORONARY ARTERY (RCA) HAD 75% STENOSIS. THE PHYSICIAN ATTEMPTED TO PLACE A NON-BSC STENT IN THE LAD, BUT WAS UNABLE TO CROSS THE LESION. A (DIAMETER UNKNOWN) 24MM LIBERTE BARE METAL STENT WAS DEPLOYED NEAR THE PROXIMAL LAD. A DISSECTION OCCURRED DURING THE PROCEDURE. HOWEVER, IT IS UNKNOWN WHEN IT OCCURRED. DURING FOLLOW-UP (DATE UNKNOWN), THE PHYSICIAN CONFIRMED IN-STENT RESTENOSIS IN THE PROXIMAL LAD. SEVEN MONTHS POST THE INITIAL INTERVENTION, CORONARY ANGIOGRAPHY WAS PERFORMED. THERE WAS NO PROBLEM IN THE RCA. THE DISSECTION IN THE PROXIMAL LAD WAS CORRECTED. PRE-IVUS WAS PERFORMED. INCOMPLETE APPOSITION AND REMAINING LESIONS AT BOTH ENDS OF THE PREVIOUSLY PLACED LIBERTE STENT WERE IDENTIFIED. THE LESION WAS PREDILATED TWICE WITH A 2.5X15MM QUANTUM MAVERICK TO 16ATMS. TWO (SIZE UNKNOWN) NON BSC STENTS WERE DEPLOYED IN THE LESION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DELIVERYS YSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention CYPHER STENT