BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 1981971 · Received February 8, 2011

    Report

    Report Number
    2134265-2011-00178
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: OUTCOMES ATTRIB. TO AE, DEATH DATE, DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY, PATIENT CODES. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL 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).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, THERAPY DATES & DESC., OTHER RELEVANT HISTORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2011, THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM VIA EMS AND WAS UNRESPONSIVE AND INTUBATED. THE INITIAL EMS RESPONSE WAS FOR A RESPIRATORY PROBLEM. UPON ARRIVAL AT THE EMERGENCY ROOM, CARDIAC RHYTHM WAS ASYSTOLE AND THE PATIENT WENT INTO VENTRICULAR FIBRILLATION WHICH WAS TREATED WITH MEDICATION AND DEFIBRILLATION X3 WITHOUT SUCCESS. THE PATIENT DIED OF CARDIAC ARREST. A DEATH CERTIFICATE WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    SAME PATIENT AS MFR REPORT #: 2134265-2012-00218. IT WAS FURTHER REPORTED THAT THE ANGIOPLASTY AT THE REINTERVENTION PROCEDURE IN (B)(6) 2010 USED A NC QUANTUM APEX 3.5X8MM, HOWEVER, THERE WAS DIFFICULTY MAINTAINING POSITION OF THE BALLOON ACROSS THE SHORT FOCAL LESION DUE TO WATERMELON SEEDING OF THE BALLOON. HENCE THIS WAS EXCHANGED FOR A LONGER NC QUANTUM APEX 3.5X12MM BALLOON WHICH WAS SUCCESSFULLY INFLATED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 3.2X6.0MM TARGET LESION LOCATED IN THE BIFURCATED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT UTILIZED A DIRECT STENT TECHNIQUE WITH A 3.0X8.0MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 5 DAYS LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT WAS ADMITTED WITH COUGH AND FEVER. CHEST X-RAY REVEALED MILD FLUID OVERLOAD OR CONGESTIVE HEART FAILURE PATTERN WITH NO FOCAL INFILTRATES. THE PATIENT HAD ELEVATED TROPONINS. CLINICAL DIAGNOSIS WAS REPORTED AS MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. REINTERVENTION SIX DAYS LATER, TREATED THE MID LAD WITH BALLOON ANGIOPLASTY RESULTING IN 20% RESIDUAL STENOSIS. A NON TARGET VESSEL IN THE LEFT CIRCUMFLEX ARTERY WAS TREATED WITH AN UNSPECIFIED DRUG ELUTING STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389378300 13382496

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R PROWATER GUIDE LINER| 3.5X12MM ENDEAVOR STENT