BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 4170941 · Received October 14, 2014

    Report

    Report Number
    2134265-2014-06058
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    July 14, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: (B)(6) 2011. 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2014-05149, 2134265-2014-05312 AND 2134265-2014-05160. (B)(4). IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2011, A 2.75MM X 8MM AND A 2.5MM X 32MM TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT WAS IMPLANTED IN MID LEFT ANTERIOR DESCENDING (LAD) AND DISTAL LAD ARTERY RESPECTIVELY. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND CORONARY ANGIOGRAPHY WAS PERFORMED. THE NEXT DAY THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A RESTENOTIC LESION OF PREVIOUSLY PLACED 2.75 X 8 MM TAXUS STENT LIBERTE STENT LOCATED IN THE MID LAD WITH 80% STENOSIS AND WAS 5MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. ALSO, THERE WAS A RESTENOSIS OF A PREVIOUSLY PLACED 2.5 MM X 32 MM TAXUS LIBERTE STENT IN THE DISTAL LAD. THE LESIONS WERE TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.0MM X 12 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN. IN (B)(6) 2014, THE PATIENT WAS PRESENTED DUE TO SHORTNESS OF BREATH, INTERMITTENT DRY COUGH AND OBSTRUCTIVE SLEEP APNEA WHICH WAS DIAGNOSED AS PNEUMONITIS. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. THREE DAYS FROM ADMISSION, THE PATIENT EXPERIENCED ATYPICAL CHEST PAIN WHICH WAS DIAGNOSED AS UNSTABLE ANGINA. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 95% RESTENOSIS OF THE PREVIOUSLY PLACED 2.75 MM X 8 MM TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT AND 3.0MM X 12 MM ION¿ STENT LOCATED IN MID LAD AND 60%-70% DIFFUSE NARROWING OF THE PREVIOUSLY PLACED 2.5 MM X 32 MM TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT IN DISTAL LAD. THERE WAS NO INTERVENTION PERFORMED IN DISTAL LAD AND THE MID LAD WAS THEN TREATED WITH BALLOON ANGIOPLASTY USING A 2.25 X 12MM EMERGE. HOWEVER, POST INFLATION, THE PATIENT COMPLAINED OF CHEST PAIN WHICH WAS DUE TO A SPASM. THIS WAS TREATED WITH INTRAVENOUS (IV) NITROGLYCERINE. THE CHEST PAIN WAS RESOLVED AND THE PHYSICIAN THEN DEPLOYED A 2.5 MM X 16 MM AND 2.5 MM X 20 MM ION¿ STENT IN AN OVERLAPPING MANNER. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. SIX DAYS POST PROCEDURE, THE EVENT ANGINA WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS AND PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649117 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization