BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1648131 · Received April 1, 2010

    Report

    Report Number
    2134265-2010-01530
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).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

    SAME CASE AS 2134265-2010-01531. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS AND PATIENT DEATH OCCURRED. THE PATIENT INITIALLY PRESENTED WITH A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS GOING TO TREAT THE LESION BUT THEN ABORTED THE PROCEDURE AND SENT THE PATIENT FOR SURGICAL CONSULT. THE PATIENT WAS REFUSED FOR SURGICAL CONSULT AND RETURNED TO CATH LAB TWO DAYS LATER. THE LESION IN THE RCA WAS PRE-DILATED WITH A NON-BSC 2.5X20MM BALLOON. THE PHYSICIAN IMPLANTED A 2.5X32MM TAXUS LIBERTE¿ MR IN THE RCA. THEN A SECOND STENT, 2.75X38MM TAXUS LIBERTE¿ LONG MR WAS IMPLANTED PROXIMAL TO THE FIRST STENT IN THE RCA. BOTH STENTS WERE POST-DILATED WITH A 2.75X20M QUANTUM BALLOON. ANGIOMAX WAS ADMINISTERED DURING THE PROCEDURE. TWO DAYS POST-PROCEDURE, THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION (MI) AND IT WAS FOUND THE RCA WAS 100% THROMBOSED AT THE PROXIMAL EDGE OF THE PROXIMAL STENT (2.75X38MM). AT THE TIME OF THE EVENT, THE PHYSICIAN BELIEVED THE PATIENT WAS RECEIVING ANTI-PLATELET THERAPY BUT TYPE AND DOSAGE NOT PROVIDED. THE PHYSICIAN WIRED THE VESSEL AND USED A SERIES OF BALLOONS TO RE-OPEN THE VESSEL (2.75X20MM MAVERICK, 2.5X15MM MAVERICK, 2.5X12MM NON-BSC BALLOON, 2.0X15MM MAVERICK, 2.75X12MM QUANTUM MAVERICK AND 2.75X20MM QUANTUM) AND REGAINED TIMI 3 FLOW. THE PATIENT WAS MOVED TO A ROOM. THE NEXT DAY MI OCCURRED AGAIN AND THE PATIENT PASSED AWAY. THE PHYSICIAN FELT THAT THE RCA RE-THROMBOSED AND THE PATIENT IMMEDIATELY PASSED. NO FURTHER INFORMATION IS PROVIDED.

    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 H7493893638270 12735271

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death QUANTUM 2.75X20MM BALLOON| TAXUS LIBERTE' 2.5X32MM STENT| SPRINTER 2.5X20MM BALLLON