BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 3051406 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02112
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. THE DEVICE WAS NOT RETURNED. 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) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. LESION #1 WAS A DE-NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 20 MM ION STENT, WITH 0% RESIDUAL STENOSIS. LESION 2 WAS A DE-NOVO LESION LOCATED IN THE MID LAD WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 3.00 MM X 16 MM ION STENT WITH 0% RESIDUAL STENOSIS. LESION 3 WAS A DE-NOVO LESION LOCATED IN THE 2ND OBTUSE MARGINAL WITH 85% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 28 MM ION STENT, WITH 10% RESIDUAL STENOSIS. ADDITIONALLY 85% STENOSIS LOCATED IN THE 1ST OBTUSE MARGINAL HAS BEEN TREATED WITH LUGE WIRE AND NON-BSC BALLOON WITH 25% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT WAS HOSPITALIZED AND A STRESS TEST WAS PERFORMED WHICH REVEALED ABNORMAL RESULTS. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED RESTENOSIS. THE 75% PROXIMAL EDGE RESTENOSIS OF PREVIOUSLY PLACED STUDY STENT LOCATED IN MID LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3.00MM X 33 MM NON BSC DRUG ELUTING STENT WITH 5% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148264 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416300 14815985

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention