BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2071791 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01491
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY PATIENT CODE AND RELEVANT TESTS/LAB DATA UPDATED. RELEVANT TESTS/LAB DATA CORRECTED LCX STENOSIS FROM 85% TO 80-90%. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE 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).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA. LESION #1 WAS LOCATED IN THE RAMUS WITH 90% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, AND IMPLANTING A 2.25 MM X 8 MM TAXUS LIBERTE STENT AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. LESION #2 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.25 MM X 12 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. THERE WAS 85% DIFFUSE IN-STENT RESTENOSIS IN THE RAMUS. AT THE 247 DAYS POST INDEX PROCEDURE, THE RAMUS WAS TREATED WITH PLACEMENT OF A DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RAMUS WAS TREATED WITH PLACEMENT OF A 2.5 X 8 MM NON BSC DRUG ELUTING STENT. DURING THIS INTERVENTION, THE PDA WAS ALSO TREATED WITH PLACEMENT OF A 2.5 X 12 MM NON BSC DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS.

    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 - GALWAY H749389368220 12913538

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention 2.25X12MM TAXUS LIBERTE STENT