BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 3033666 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-02004
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 5, 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)(6). 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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD ANGINA AND IN-STENT RESTENOSIS. IN (B)(6) 2012, THE PATIENT PRESENTED STABLE ANGINA (CCS CLASSIFICATION 4) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS AN IN-STENT RESTENOSED LESION OF AN UNKNOWN DRUG-ELUTING STENT LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (DIST LCX) WITH 80% STENOSIS AND WAS 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.75X20MM ION STENT, WITH 10% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH RECURRENT UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. 70-90% PROXIMAL TO MID RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN THE LCX WAS NOTED AND TREATED WITH PRE-DILATION AND PLACEMENT OF THREE NON-BSC STENTS OF SIZE 3X30MM, 3X15MM AND 3X12MM PLACED IN TANDEM WITH EACH OTHER. POST-DILATION WAS ALSO PERFORMED. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137109 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420270 13995723

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R