BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2070301 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01440
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A CEREBRAL HEMORRHAGE AND CARDIAC ARREST. THE PATIENT WAS HOSPITALIZED DUE TO A CONDITION OF PAROXYSMAL PALPITATIONS, CHEST TIGHTNESS AND RESPIRATORY DISTRESS WHICH HAD BEEN OCCURRING FOR THE PAST TEN YEARS. THE PATIENT'S SYMPTOMS BEGAN TO DETERIORATE WITHIN THE LAST 20 DAYS. THE PATIENT WAS PUT ON TWO HYPERTENSIVE DRUGS. TWO DAYS AFTER THE PATIENT WAS ADMITTED, THE PATIENT EXPERIENCED A FEVER, COUGH AND SMALL AMOUNT OF YELLOW SPUTUM; THE PATIENT WAS PUT ON ANTIBIOTICS FOR FIVE DAYS. TWO DAYS AFTER THE PATIENT¿S TEMPERATURE WAS REGULATED, ANGIOGRAPHY WAS PERFORMED AND A HIGH GRADE STENOSIS WAS FOUND IN THE FIRST DIAGONAL BRANCH AND MID LEFT CIRCUMFLEX ARTERY (LCX). ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 2.75X24MM DENOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT CIRCUMFLEX ARTERY (LCX). TWO NON BSC STENTS, SIZES 3.0X23MM AND 2.25X15MM, WERE IMPLANTED IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DIAGONAL BRANCH AND POSTDILATION WAS PERFORMED WITH A KISSING BALLOON TECHNIQUE. A 2.75X24MM TAXUS LIBERTE STENT WAS THEN IMPLANTED IN THE MID LCX. ANGIOGRAM AFTER THE PROCEDURE CONFIRMED GOOD STENT EXPANSION WITH TIMI 3 FLOW. AN INTRAVENOUS DRIP OF LOW MOLECULAR HEPARIN WAS GIVEN TO THE PATIENT. TWO DAYS LATER THE PATIENT EXPERIENCED AN ACUTE CEREBRAL HEMORRHAGE. ANTICOAGULATION TREATMENT WAS STOPPED AND TREATMENT TO REDUCE INTRACRANIAL PRESSURE WAS APPLIED. THE PATIENT DEVELOPED APNEA AND UNDERWENT CARDIAC ARREST. AFTER A SERIES OF "RESCUE", THE PATIENT¿S VITAL SINGS WERE STABLE AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY AT THE FAMILY'S DISCRETION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    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 - GALWAY H7493894024270 13426777

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 2.25X15MM XIENCE V STENT| 3.0X23MM XIENCE V STENT