BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® LONG

    MDR report key: 3242615 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04986
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    October 25, 2010
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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

    (B)(6) CLINICAL TRIAL. SAME CASE AS MDR ID # 2134265-2013-04985, MDR ID # 2134265-2013-05101. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, ST ELEVATION WITH CHEST DISCOMFORT, MYOCARDIAL INFARCTION AND DISTAL EMBOLIZATION OCCURRED. IN (B)(6) 2010, THE SUBJECT PRESENTED WITH CHEST DISCOMFORT RADIATING TO BOTH ARMS WITH SHORTNESS OF BREATH. THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA WITH ACUTE CORONARY SYNDROME. CARDIAC CATHETERIZATION WAS RECOMMENDED. TARGET LESION #1 WAS A DE NOVO LESION, LOCATED IN THE ATRIOVENTRICULAR ARTERY (RPAV) WITH 80% STENOSIS AND WAS 5 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF A 2.50MM X 8 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. PER SOURCE, THE TARGET LESION #1 WAS DISTAL RIGHT POSTEROLATERAL ARTERY (RPL) WHICH WAS TREATED WITH 2.5M X 12 MM TAXUS LIBERTE STENT. TARGET LESION #2 WAS A DE NOVO LESION, WITH A PRE-EXISTING INTRALUMINAL THROMBUS IN THE MID SEGMENT, LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING INTO DISTAL RCA WITH 90% STENOSIS AND WAS 38 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. TARGET LESION # 2 WAS TREATED WITH THROMBECTOMY OF MID RCA LESION FOLLOWED BY PLACEMENT OF A 4.00MM X 12 MM TAXUS LIBERTE STENTS ANOTHER 4.00MM X 38MM TAXUS LIBERTE STENT WAS PLACED FROM THE MID RCA THROUGH THE PROXIMAL RCA WITH AN OVERLAPPING 4.00 X 12 MM TAXUS LIBERTE STENT PLACED MORE PROXIMALLY. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS 0%. PER SOURCE THE TARGET LESION # 2 IS PROXIMAL RCA EXTENDING UP TO RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). FOLLOWING STENT PLACEMENT AND POST DILATION, THE PATIENT EXPERIENCED ST ELEVATION WITH CHEST DISCOMFORT. DISTAL EMBOLIZATION WAS NOTED WHICH WAS TREATED MEDICALLY. IN ADDITION, A 4.0MM X 8MM TAXUS LIBERTE STENT WAS PLACED OVERLAPPING THE 4.00MM X 38MM TAXUS LIBERTE STENT TO TREAT PRE-EXISTING FILLING DEFECT AND PLAQUE RUPTURE WITH 0% RESIDUAL STENOSIS. THREE DAYS POST-PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342945 TAXUS® LIBERTÉ® LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893638400 12730119

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention