BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1101730 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02231
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 10, 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
    CT, 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: 2134265-2008-02232, 2134265-2008-02229. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A STENT EMBOLIZATION OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED DISTAL SAPHENOUS VEIN GRAFT (SVG) TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE FIRST INFLATION OF THE 3.0X12MM MAVERICK BALLOON IN THE SVG LESION, THE BALLOON BURST AND STUCK IN THE VESSEL. THE PHYSICIAN PULLED THE MAVERICK SHAFT TO DISLODGE BALLOON, BUT WAS UNSUCCESSFUL. HE THEN TRIED ADVANCING IT AND PULLING BACK, THIS TOO WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO USE A 3.0X8MM QUANTUM MAVERICK BALLOON ALONG SIDE OF THE BURST MAVERICK. HE PARTIALLY INFLATED THE QUANTUM BALLOON, TO TRY TO DISLODGE THE MAVERICK, BUT THE QUANTUM BALLOON BURST. THE QUANTUM BALLOON WAS REMOVE INTACT, WITHOUT INCIDENT. THE PHYSICIAN AGAIN ATTEMPTED TO REMOVE THE MAVERICK BALLOON AND WAS SUCCESSFUL. HOWEVER, ONCE THE MAVERICK SHAFT WAS REMOVED, THE PHYSICIAN FOUND THE BALLOON WAS NOT ATTACHED. THE BALLOON AND BOTH RADIOPAQUE MARKERS WERE STILL IN THE VESSEL. THE PHYSICIAN USED A SNARE TO SUCCESSFULLY RETRIEVE THE BALLOON AND ONE OF THE RADIOPAQUE MARKERS. THE REMAINING RADIOPAQUE MARKER WAS APPROX 5 MM DISTAL TO THE LESION. THE PHYSICIAN TACKED THE MARKER UP AGAINST THE SVG WALL WITH A 2.5X14MM NON-BSC BARE METAL STENT. THE PHYSICIAN ATTEMPTED TO CROSS THE ORIGINAL SVG LESION WITH A 3.00X8MM LIBERTE BARE METAL STENT, BUT WAS UNABLE TO CROSS THE LESION. DURING REMOVAL OF THE LIBERTE STENT, THE STENT EMBOLIZED OFF THE BALLOON CATHETER. THE STENT WAS JUST PROXIMAL TO THE SVG LESION. THE PHYSICIAN TACKED IT UP WITH A 1.5X20MM NON-BSC BALLOON AND THEN FOLLOWED WITH A 3.0 NON-BSC BALLOON. HE THEN ADVANCED A 3.0X14MM NON-BSC STENT ACROSS THE ORIGINAL SVG LESION WITH PROCEDURAL SUCCESS. THE PROCEDURE TIME WAS IN EXCESS OF THREE HOURS. PT STATUS REPORTED AS "OK".

    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 9583922

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention DRIVER STENT| MICRODRIVER STENT| SPRINTER BALLOON