BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (R) LIBERTÉ (R) ATOM (TM)

    MDR report key: 1994233 · Received February 17, 2011

    Report

    Report Number
    2134265-2011-00254
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    August 10, 2010
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS/LAB DATA CORRECTED LMCA: WIDELY PATENT; LAD: 80% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT IN THE MID LAD; 80-90% OSTIAL IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT IN THE 1ST DIAGONAL; LCX: 80% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT IN THE PROXIMAL LCX. NOT RCA: KNOWN OCCLUSION WITH BYPASS GRAFT TO THE RIMA TO DISTAL PORTION WITH DIFFUSE NON-OBSTRUCTIVE DISEASE; MID LAD: 80% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT; 1ST DIAG: 80% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT; PROX CX: 80% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT. AS PREVIOUSLY STATED, AND UPDATED WITH ADDITIONAL RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A 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)(4). SAME PATIENT AS 2134265-2011-00017. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. LESION 1 WAS A BIFURCATED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY WITH 80% IN-STENT RESTENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.00 MM X 32 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. LESION 2 WAS A BIFURCATED LESION LOCATED IN THE 1ST DIAGONAL WITH 80% IN-STENT STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.25 MM X 16 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. LESION 3 WAS LOCATED IN THE PROXIMAL CIRCUMFLEX WITH 80% IN-STENT STENOSIS AND WAS 34 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.00 MM X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%.THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. DURING THE INDEX PROCEDURE, THE 2.25 X 16 MM TAXUS LIBERTE STENT WAS REMOVED BEFORE DEPLOYMENT DUE TO DAMAGE TO THE TIP OF THE STENT STRUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME PATIENT AS 2134265-2011-00017. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. LESION 1 WAS A BIFURCATED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY WITH 80% IN-STENT RESTENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.00 MM X 32 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. LESION 2 WAS A BIFURCATED LESION LOCATED IN THE 1ST DIAGONAL WITH 80% IN-STENT STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.25 MM X 16 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. LESION 3 WAS LOCATED IN THE PROXIMAL CIRCUMFLEX WITH 80% IN-STENT STENOSIS AND WAS 34 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.00 MM X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%.THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. DURING THE INDEX PROCEDURE, THE 2.25 X 16 MM TAXUS LIBERTE STENT WAS REMOVED BEFORE DEPLOYMENT DUE TO DAMAGE TO THE TIP OF THE STENT STRUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) ATOM (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 3.00X38MM TAXUS LIBERTE| 3.00X32MM TAXUS LIBERTE