BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3864215 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03139
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.:THE 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

    IT WAS FURTHER REPORTED THAT THE STUDY STENT IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WAS PATENT, AND NO IN-STENT RESTENOSIS WAS NOTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID:2134265-2014-03138. (B)(4) STUDY. IT WAS REPORTED THAT CHEST PAIN RADIATING TO BOTH ARMS ASSOCIATED WITH SHORTNESS OF BREATH, MYOCARDIAL INFARCTION (MI) AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH INTERMITTENT CHEST PAIN ASSOCIATED WITH NAUSEA AND THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION # 1 WAS DE-NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH 80% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.60 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 8 MM TAXUS® LIBERTÉ® STENT, WITH 0% RESIDUAL STENOSIS. TARGET LESION # 2 WAS DE-NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.80 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 24 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS DE-NOVO OSTIAL LESION LOCATED IN THE DISTAL RCA WITH 80% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 X 8 MM TAXUS® LIBERTÉ® STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014, THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN RADIATING TO BOTH ARMS ASSOCIATED WITH SHORTNESS OF BREATH AND THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. TROPONIN WAS FOUND TO BE ELEVATED. ECG REVEALED INVERTED T WAVES. THE PATIENT WAS DIAGNOSED WITH NON Q-WAVE, NON ST ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF THE EVENT, THE PATIENT WAS ONLY ON ASPIRIN. THE STUDY DRUG WAS LAST TAKEN IN DECEMBER 2012 AND OTHER ANTIPLATELET MEDICATION WAS NEVER TAKEN DURING THE COURSE OF STUDY. ONE DAY FROM THE ADMISSION, THE 95% IN-STENT RESTENOSIS OF THE STUDY STENT IN MID RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2.5 X 28 MM NON BSC DRUG ELUTING STENT, RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338136 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389378300 13253146

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R