BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? ELEMENT? LONG

    MDR report key: 4813369 · Received June 2, 2015

    Report

    Report Number
    2134265-2015-03258
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    June 11, 2013
    Report Date
    May 4, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(6). IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2011, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED A DE-NOVO LESION LOCATED IN THE PROXIMAL RIGHT CORONARY (RCA) ARTERY EXTENDING INTO THE MID RCA WITH 99% STENOSIS AND WAS 36 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00 X 38 MM TAXUS ELEMENT STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL FOR A REPEAT ANGIOGRAPHY WHICH REVEALED 100% OCCLUSION TO THE RCA. IN (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE RCA. THE 100% TOTALLY OCCLUSIVE RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN THE PROXIMAL RCA EXTENDING INTO THE MID RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5 X 24MM NON-BSC DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354002 TAXUS? ELEMENT? LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902538400

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention