BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832227 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03985
    Event Type
    Death
    Date Received
    September 13, 2010
    Date of Event
    December 28, 2009
    Report Date
    August 20, 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

    (B)(4). DEVICE IS COMBINATION PRODUCT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 ON FDA REPORT (B)(4) THAT POST A STENTING PROCEDURE, A VESSEL OCCLUSION AND PATIENT DEATH OCCURRED. THE PATIENT PRESENTED TO AN OUTLYING ER WITH CHEST PAIN THAT HAD STARTED ONE WEEK PRIOR. THE PATIENT WAS TRANSFERRED TO THE REPORTING FACILITY FOR FURTHER TREATMENT. THE LESIONS BEING TREATED WERE LOCATED IN THE 99% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, 100% OCCLUDED MID LAD, AND 100% OCCLUDED PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.0X20MM TAXUS LIBERTE STENT WAS DEPLOYED IN THE LAD FOLLOWED BY A 2.75X8MM TAXUS LIBERTE STENT DEPLOYED JUST DISTAL TO THE 3.0X20MM TAXUS LIBERTE STENT IN AN OVERLAPPING FASHION. THE OVERLAPPED SEGMENT WAS DILATED WITH A 3.0X15MM QUANTUM MAVERICK BALLOON. THEN THE RCA WAS PREDILATED WITH A 3.0X15MM QUANTUM MAVERICK BALLOON AND A 2.75X32MM TAXUS LIBERTE STENT WAS DEPLOYED. THE PROXIMAL PORTION OF THE STENT WAS DILATED WITH A 3.25X15MM QUANTUM MAVERICK BALLOON. FINAL FILMS REVEALED 0% RESIDUAL STENOSIS AND TIMI III FLOW IN BOTH VESSELS. THE PATIENT WAS TREATED WITH ASA, PLAVIX, HEPARIN, AND ANGIOMAX. THE CASE CONCLUDED AND THE PATIENT WAS TRANSPORTED TO THE CCU. APPROXIMATELY 3 ½ HOURS POST THE INITIAL PROCEDURE, THE PATIENT COMPLAINED OF CHEST DISCOMFORT AND SINUS TACHYCARDIA WAS NOTED ON THE MONITOR. APPROXIMATELY 1 HOUR LATER, THERE WERE NO IMPROVEMENTS IN CHEST PAIN OR RHYTHM DESPITE MEDICAL TREATMENT. THE PATIENT WAS TAKEN EMERGENTLY BACK TO CARDIAC CATH LAB, APPROXIMATELY 6 HOURS POST THE INITIAL PROCEDURE, WHERE FILMS REVEALED THE PROXIMAL LAD AND PROXIMAL RCA WERE TOTALLY OCCLUDED AT THE SITE OF PREVIOUSLY PLACED STENTS. ARRANGEMENTS WERE MADE FOR AN EMERGENT CAB. PROFOUND CARDIOGENIC SHOCK WAS IDENTIFIED. THE PATIENT WAS INTUBATED AND VENTILATED. THE PATIENT BECAME ASYSTOLE. CPR WAS INITIATED AND A TEMPORARY PACER INSERTED. APPROXIMATELY 1 HOUR AND 40 MINUTES LATER, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A "SALVAGE CABX3". EVIDENCE OF MASSIVE LEFT VENTRICULAR INFARCTION WITH INABILITY TO WEAN FROM CARDIOPULMONARY BYPASS OCCURRED. THE PATIENT WAS PRONOUNCED DEAD.

    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 H749389378270

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 3.25X15MM QUANTUM MAVERICK BALLOON| 2.75X32MM TAXUS LIBERTE STENT| 3.0X15MM QUANTUM MAVERICK BALLOON| 3.0X20MM TAXUS LIBERTE STENT