BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2231104 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03630
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 2.75X12-24MM DE NOVO AND ECCENTRIC TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.75X12MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE DISTAL RCA AND A 2.75X24MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE PROXIMAL RCA. IT WAS NOTED THAT THERE WAS STILL A RESIDUAL LESION JUST PROXIMAL TO THE STENT IN THE DISTAL RCA. A 2.75X12MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO LESION AND AFTER CROSSING THE PREVIOUSLY PLACED 2.75X24MM PROMUS ELEMENT STENT, THE TAXUS LIBERTE STENT DISLODGED FROM THE SDS IN THE PROXIMAL RCA. A 2.5X9MM NON BSC BALLOON WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL. A 2.75X16MM TAXUS LIBERTE STENT WAS THEN DEPLOYED AT 14ATMS, COVERING THE RESIDUAL LESION AND OVERLAPPING THE DISTAL STENT. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (TM) LIBERTÉ (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012270 0013933146

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 2.75X12MM PROMUS ELEMENT STENT| 2.75X24MM PROMUS ELEMENT STENT| 0.014 190 CM WHISPER MS SUPPORT GUIDE WIRE| JR4 LAUNCHER GUIDE CATHETER