BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION¿

    MDR report key: 2800153 · Received October 22, 2012

    Report

    Report Number
    2134265-2012-06346
    Event Type
    Death
    Date Received
    October 22, 2012
    Date of Event
    May 25, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME PATIENT AS MDR ID#: 2134265-2012-06345, 2134265-2012-06347. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASS UNKNOWN) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 1ST DE NOVO TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO 3RD OBTUSE MARGINAL BRANCH (OM3) WITH 90% STENOSIS AND WAS 6MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.50X16MM ION STENT, WITH 0% RESIDUAL STENOSIS. THE 2ND DE NOVO TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.25X28MM ION STENT, WITH 0% RESIDUAL STENOSIS. THE 3RD DE NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) WITH 80% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.50X16MM ION STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT EXPERIENCED HEART ATTACK AND DIED ON THE SAME DAY. NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE CAUSE OF DEATH WAS HEART ATTACK.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 1ST OSTIAL LONG TARGET LESION TREATED IN THE INDEX PROCEDURE WAS UPDATED TO SVG EXTENDING FROM 1ST OBTUSE MARGINAL BRANCH (OM) TO 3RD OM. PER SOURCE, THE PRIMARY CAUSE OF DEATH WAS CARDIAC ARREST AND THE UNDERLYING CAUSE WAS CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902316250 14432214

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death