BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2052900 · Received April 13, 2011

    Report

    Report Number
    2134265-2011-01235
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2011-01234. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERY (RCA). A 2.75X38MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD AND THE STENT WAS SUCCESSFULLY DEPLOYED. A 2.75X28MM TAXUS LIBERTE SDS WAS ADVANCED TO THE RCA AND THE STENT WAS DEPLOYED. AT THE END OF THE PROCEDURE, THE PATIENT HAD A "LOWISH" SYSTOLIC BLOOD PRESSURE OF 90-95, HOWEVER NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. WHILE IN THE RECOVERY AREA, THE PATIENT DEVELOPED CHEST PAIN AND ST CHANGES. THE PATIENT WAS TAKEN FOR REPEAT CORONARY ANGIOGRAPHY WHICH REVEALED A TOTALLY OCCLUDED LAD AND A 70% OCCLUSION FORMING IN THE STENT IN THE RCA. THE PATIENT WAS ADMINISTERED ANGIOMAX AND HEPARIN. NEXT, MULTIPLE DILATIONS WERE PERFORMED ALONG THE ENTIRE LENGTH OF THE STENT IN THE LAD. AN EXPORT THROMBECTOMY ASPIRATION CATHETER WAS ALSO USED AND IT WAS CONFIRMED THAT THE LAD WAS REOPENED. NEXT, THE RCA WAS RE-DILATED AND THE CLOTS WERE RESOLVED. PER THE PHYSICIAN, THE PATIENT HAD A HYPERCOAGULABLE CONDITION. THE PATIENT WAS ADMINISTERED HEPARIN FOR 24HOURS AND WILL CONTINUE ON ANTICOAGULATION AND ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893738270 13891750

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention