BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2161428 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02984
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 6, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. 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

    EVENT DATE CORRECTED FROM (B)(6) 2011 TO (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS 2134265-2011-02983. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WITH 75% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION BY IMPLANTING TWO TAXUS LIBERTE (3.5 X 28 MM AND 4.0 X 8 MM) STENTS IN AN OVERLAPPING FASHION. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. AT 294 DAYS POST INDEX PROCEDURE THE PATIENT EXPERIENCED ANGINA AND WAS HOSPITALIZED. PATIENT UNDERWENT PCI WHICH REVEALED A 50% STENOSIS WITH TIMI 3 FLOW IN THE MID RCA AND A 60% STENOSIS WITH TIMI 3 FLOW IN THE PROXIMAL RCA. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2 OVERLAPPING NON BSC DRUG ELUTING STENTS. POST TREATMENT DIAMETER STENOSIS WAS 0% WITH TIMI 3 FLOW. THE SUBJECT WAS DISCHARGED LATER THAT DAY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2011, THE PATIENT WAS SEEN IN THE OFFICE FOR EVALUATION OF RECURRENT CHEST PAIN SINCE THE INDEX PROCEDURE. CORONARY ANGIOGRAPHY REVEALED DIFFUSE 50-60% IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED STUDY STENTS IN THE OSTIAL TO MID RCA. THE PROXIMAL AND MID RCA WERE TREATED WITH PLACEMENT OF TWO OVERLAPPING 3.5X28MM AND 4.0X12MM NON-BSC DRUG ELUTING STENTS WITH 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. ASPIRIN AND PRASUGREL WERE CONTINUED.

    Description of Event or Problem · 1

    (B)(6). SAME CASE AS 2134265-2011-02983. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WITH 75% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION BY IMPLANTING TWO TAXUS LIBERTE (3.5 X 28 MM AND 4.0 X 8 MM) STENTS IN AN OVERLAPPING FASHION. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. (B)(6) POST INDEX PROCEDURE THE PATIENT EXPERIENCED ANGINA AND WAS HOSPITALIZED. PATIENT UNDERWENT PCI WHICH REVEALED A 50% STENOSIS WITH TIMI 3 FLOW IN THE MID RCA AND A 60% STENOSIS WITH TIMI 3 FLOW IN THE PROXIMAL RCA. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2 OVERLAPPING NON BSC DRUG ELUTING STENTS. POST TREATMENT DIAMETER STENOSIS WAS 0% WITH TIMI 3 FLOW. THE SUBJECT WAS DISCHARGED LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389368400 13092796

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention 3.50X28MM TAXUS LIBERTE STENT