BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2992953 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01210
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION DEVICE. DEVICE EVALUATED BY MANUFACTURER: 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)(4). SAME CASE AS 2134265-2013-01211. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (1ST OM) WITH 70% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.75 X 24 MM TAXUS LIBERTE STENT AND POST-DILATATION WITH 10% RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, A NON-TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WAS ALSO TREATED WITH PLACEMENT OF A 3.0 X 28 MM NON BSC STENT AND POST DILATATION WITH LESS THAN 10% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, AN ION STENT WAS PLACED IN THE 1ST OBTUSE MARGINAL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH RECURRENT CHEST DISCOMFORT WITH EXERTION AND AT REST. THE PATIENT HAD A POSITIVE STRESS TEST OF APICAL AREA. AT THE TIME OF THE EVENT THE PATIENT WAS ON ASPIRIN AND STUDY DRUG PER PROTOCOL. THE 70-80% IN-STENT RESTENOSIS OF PREVIOUSLY PLACED STENTS IN LCX (STUDY STENT, ION STENT AND NON BSC STENT) WAS TREATED WITH ANGIOPLASTY AND PLACEMENT OF 3 NON BSC DRUG ELUTING STENTS (3.00 X 30 MM : DISTAL LCX EXTENDING TO PROXIMAL LCX 3.00 X 15 MM : PROXIMAL LCX AND 3.00 X 12 MM : OSTIAL TO PROXIMAL LCX. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS LESS THAN 10%. THE 80% DIFFUSE IN-STENT RESTENOSIS IN 1ST OM WAS TREATED WITH BALLOON ANGIOPLASTY, AND PLACEMENT OF A DRUG ELUTING STENT WITH 10% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96847 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902438300 14229001

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention