BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3520681 · Received December 16, 2013

    Report

    Report Number
    2134265-2013-08804
    Event Type
    Injury
    Date Received
    December 16, 2013
    Date of Event
    May 22, 2013
    Report Date
    November 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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).

    Additional Manufacturer Narrative · 1

    EVENT DATE- CORRECTED FROM (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT WORSENING CORONARY ARTERY DISEASE AND IN-STENT RESTENOSIS OCCURRED. THE PATIENT HAD AN UNSPECIFIED TAXUS STENT IMPLANTED IN THE 1ST OBTUSE MARGINAL (OM) ARTERY ON AN UNSPECIFIED DATE. IN NOVEMBER 2012, THE SUBJECT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS AN IN-STENT RESTENOSIS OF PREVIOUSLY PLACED BAREMETAL STENT LOCATED IN THE PROXIMAL LAD WITH 70% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 16 MM PROMUS ELEMENT PLUS STENT WITH 0% RESIDUAL STENOSIS. OFF NOTE, THE COMPLAINT HAS BEEN SENT FOR THE TAXUS STENT PLACED PREVIOUSLY IN THE PROXIMAL LAD. ONE DAY POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2013, THE SUBJECT PRESENTED DUE TO WORSENING CORONARY ARTERY DISEASE AND REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY WAS DONE AND A 90% IN-STENT RESTENOSIS OF THE PREVIOUSLY IMPLANTED TAXUS STENT, LOCATED IN THE LEFT CIRCUMFLEX ARTERY, WAS FOUND. IN (B)(6) 2013, THE SUBJECT WAS HOSPITALIZED DUE TO WORSENING CORONARY ARTERY DISEASE. THE FOLLOWING DAY, THE SUBJECT WAS TREATED WITH 5-VESSEL CORONARY ARTERY BYPASS GRAFT (CABG) INCLUDING LIMA TO LAD, SEQ EVH OM1, OM2, SEQ EVH PVL AND PDA. FOUR DAYS POST HOSPITALIZATION, THE EVENT WAS CONSIDERED AS RESOLVED AND THE SUBJECT WAS DISCHARGED ON CLOPIDOGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN-STENT RESTENOSIS OF PREVIOUSLY PLACED DRUG ELUTING STENT AND NOT A BAREMETAL STENT AS PREVIOUSLY REPORTED. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655450 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention