BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1842642 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04403
    Event Type
    Death
    Date Received
    September 23, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH DATE - (B)(6) 2009.EVENT DATE - (B)(6) 2009.IF IMPLANTED, (B)(6) 2009.(B)(4).DEVICE EVALUATED BY MFR: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEW. 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)

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM : UPDATED. (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS 2134265-2010-04402. IT WAS REPORTED IN A CONFERENCE PAPER THAT FOLLOWING A DRUG ELUTING STENT TREATMENT PROCEDURE, STENT THROMBOSIS AND DEATH OCCURRED. THE PROCEDURE WAS INDICATED DUE TO CHEST PAIN. THE 90% STENOSED TARGET LESIONS WERE LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.5X16MM TAXUS DRUG ELUTING STENT (DES) WAS IMPLANTED TO TREAT THE LESION IN THE MID RCA. A 2.5X20MM TAXUS DES WAS IMPLANTED TO TREAT THE LESION IN THE MID LAD. IVUS CONFIRMED THE STENTS WERE "PROPERLY" IMPLANTED AND THE PROCEDURE WAS COMPLETED. LATER THE SAME DAY, THE PATIENT VOMITED "LARGE" AMOUNTS OF BLOOD AND WAS DETERMINED TO BE IN SHOCK. AN EKG REVEALED ST SEGMENT ELEVATION IN LEADS AVF AND V4-V6. ENDOSCOPY EXAMINATION CONFIRMED THE PRESENCE OF BLEEDING AND REVEALED STOMACH CANCER. THE PATIENT RECEIVED A BLOOD TRANSFUSION AND THE PATIENT'S MEDICATION OF BAYASPIRIN WAS DISCONTINUED. PLAVIX AND OMEPRAL WERE CONTINUED. THE PATIENT'S BLOOD PRESSURE WAS NOTED TO ELEVATED FOLLOWING THE BLOOD TRANSFUSION AND THE PATIENT REMAINED IN SHOCK. THE PATIENT WAS PUT ON A MECHANICAL VENTILATOR. THE PATIENT'S BLEEDING STOPPED AND THE PATIENT'S BLOOD PRESSURE WAS NOTED TO BE STABLE. AT 6 DAYS LATER, THE PATIENT WAS WEANED FROM THE VENTILATOR; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DECREASED AND THE ST SEGMENT ELEVATION IN AVF, V4-V6 WERE NOTED. THROMBOSIS WAS DISCOVERED IN BOTH THE MID RCA AND MID LAD WITH 100% OCCLUSIONS IN BOTH ARTERIES. THROMBECTOMY WAS PERFORMED. A 3.0X10MM NON-BSC BALLOON WAS USED TO DILATE THE STENTS. A 3.5MM NON-BSC STENT WAS IMPLANTED IN THE PROXIMAL RCA. THEN A 3.5X28MM AND 3.5X12MM NON-BSC STENTS WERE IMPLANTED IN THE PROXIMAL LAD. PLETAL WAS GIVEN AND OMEPRAL WAS EXCHANGED TO PARIET. A "WAIT AND SEE" APPROACH WAS INITIATED; HOWEVER PNEUMONIA DEVELOPED AND THE PATIENT'S BREATHING WORSENED. AT 70 DAYS LATER, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THIS PATIENT IS THE SAME PATIENT REFLECTED MDR ID#2134265-2009-02590 AND #2134265-2009-02589.

    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 UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death