BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2112057 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02107
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 17, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR ID: 2134265-2011-02991. IT WAS FURTHER REPORTED THAT THE SAME DAY POST INDEX PROCEDURE, CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND THE PATIENT WAS DIAGNOSED AS HAVING A MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN TO TREAT THIS EVENT AND IT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT OF MYOCARDIAL INFARCTION IS UNRELATED TO THE TAXUS LIBERTE STENTS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS ONLY ONE TARGET LESION TO BE TREATED AT THE TIME OF THE INDEX PROCEDURE. IT WAS PREVIOUSLY REPORTED THAT THERE WERE TWO TARGET LESIONS. THE 99% STENOSED AND 8MM LONG TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. IT WAS TREATED WITH DIRECT STENT TREATMENT USING A 3.0X12MM TAXUS LIBERTE STENT. INTRAVASCULAR ULTRASOUND REVEALED A PLAQUE SHIFT WHICH WAS TREATED WITH PLACEMENT OF A 3.5X12MM TAXUS LIBERTE STENT AND KISSING BALLOON DILATION OF THE LEFT MAIN AND LEFT ANTERIOR DESCENDING CORONARY ARTERIES. ONLY TWO STENTS WERE DEPLOYED. IT WAS PREVIOUSLY REPORTED THAT THREE STENTS WERE DEPLOYED AT THE TIME OF THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS ONLY ONE TARGET LESION TO BE TREATED AT THE TIME OF THE INDEX PROCEDURE. IT WAS PREVIOUSLY REPORTED THAT THERE WERE TWO TARGET LESIONS. THE 99% STENOSED AND 8MM LONG TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. IT WAS TREATED WITH DIRECT STENT TREATMENT USING A 3.0X12MM TAXUS LIBERTE STENT. INTRAVASCULAR ULTRASOUND REVEALED A PLAQUE SHIFT WHICH WAS TREATED WITH PLACEMENT OF A 3.5X12MM TAXUS LIBERTE STENT AND KISSING BALLOON DILATION OF THE LEFT MAIN AND LEFT ANTERIOR DESCENDING CORONARY ARTERIES. ONLY TWO STENTS WERE DEPLOYED. IT WAS PREVIOUSLY REPORTED THAT THREE STENTS WERE DEPLOYED AT THE TIME OF THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A PLAQUE SHIFT OCCURRED. THE PATIENT PRESENTED DUE TO SILENT ISCHEMIA. CARDIAC CATHETERIZATION REVEALED 2 TARGET LESIONS. THE FIRST LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 99% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. IT WAS TREATED WITH DIRECT STENTING USING A 3.0 X 12 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. IT WAS NOTED THAT AFTER PLACEMENT OF THE STENT, INTRAVASCULAR ULTRASOUND (IVUS) REVEALED FULL STENT EXPANSION, HOWEVER PLAQUE SHIFT WAS SEEN INTO THE LMCA. THE PLAQUE SHIFT WAS TREATED BY PLACING A SECOND 3.5 X 12 MM TAXUS LIBERTE STENT. THE SECOND LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 99% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. IT WAS TREATED WITH DIRECT STENTING USING A 3.5 X 12 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. FINAL KISSING BALLOON DILATATION WAS PERFORMED IN THE LMCA AND THE LCX. FINAL ANGIOGRAPHY REVEALED TIMI III FLOW IN ALL VESSELS.

    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 H7493893612300 13581858

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention