BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3822501 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02786
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    September 17, 2013
    Report Date
    April 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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

    SAME CASE AS: 2134265-2014-02677. (B)(4). IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2005, MYOCARDIAL INFARCTION (MI) OCCURRED. THE PATIENT WAS THEN TREATED USING A 3.50 MM X 20 MM TAXUS STENT, DEPLOYED IN THE SAPHENOUS VEIN GRAFT (SVG) TO FIRST OBTUSE MARGINAL (OM). IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (CCS CLASSIFICATION-IB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE-NOVO LESION LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO DISTAL 1ST OBTUSE MARGINAL (OM) WITH 95% STENOSIS AND WAS 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 20 MM ION STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH CARDIAC CHEST PAIN AND WAS SUBSEQUENTLY DIAGONOSED WITH UNSTABLE ANGINA. ANGIOGRAPHY WAS THEN PERFORMED AND REVEALED 85% OSTIAL IN-STENT RESTENOSIS; 85% MID STENOSIS; 90% DISTAL RESTENOSIS OF PREVIOUSLY IMPLANTED ION STENT. THE 90% DISTAL DIFFUSE IN-STENT RESTENOSIS IN THE SVG TO 1ST OM WAS TREATED WITH DIRECT PLACEMENT OF 3.0 X 16 MM LONG PROMUS DRUG ELUTING STENT, FOLLOWING POST DILATATION THE RESIDUAL STENOSIS WAS 0%. SUBSEQUENTLY, HIGH-GRADE STENOSIS OF PREVIOUSLY PLACED UNKNOWN TAXUS STENT IN SVG TO 1ST OM WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 4.0 X 16 MM LONG PROMUS DRUG ELUTING STENT, WITH GOOD FINAL RESULTS. MEDICATION WAS GIVEN TO TREAT THIS EVENT. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303727 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention