BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 1831291 · Received September 10, 2010

    Report

    Report Number
    2134265-2010-04214
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE THE PATIENT DEVELOPED CHEST PAIN AND REQUIRED A TARGET VESSEL REINTERVENTION. TARGET LESION #1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WITH 90% STENOSIS AND WAS 5.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND BY IMPLANTING A 3.50 MM X 16 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY WITH 95% STENOSIS AND WAS 15.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.50 MM X 24 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2010, THE PATIENT DEVELOPED CARDIAC CHEST PAIN. CORONARY ANGIOGRAPHY REVEALED A STENT THROMBOSIS IN THE MID LAD WITH 70% STENOSIS. THE SITE HAS NOTED FOCAL IN-STENT RESTENOSIS. A TARGET VESSEL REINTERVENTION WAS PERFORMED AND THE PATIENT WAS ALSO TREATED WITH MEDICATION. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TREATMENT FOR THE STENT THROMBOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY CONSISTED OF ASPIRATION THROMBECTOMY, ANGIOPLASTY, AND IMPLANTING AN OVERLAPPING 4.0 X 12 MM TAXUS LIBERTE STENT. THE PATIENT WAS DISCHARGED 2 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 H7493893624350 12805674

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 3.50 MM X 16 MM TAXUS LIBERTE