BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION?

    MDR report key: 3148062 · Received June 5, 2013

    Report

    Report Number
    2134265-2013-03901
    Event Type
    Death
    Date Received
    June 5, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT 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)(4) STUDY. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, CONGESTIVE HEART FAILURE AND DEATH OCCURRED. IN (B)(6) 2012, THE PATIENT EXPERIENCED STABLE ANGINA (CCS CLASSIFICATION 3) WITH EPISODES OF CHEST DISCOMFORT (OCCURRING 2 TO 3 TIMES A WEEK) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 90% STENOSED DE NOVO TARGET LESION WAS LOCATED IN THE MIDDLE SAPHENOUS VEIN GRAFT TO FIRST DIAGONAL LEFT CORONARY ARTERY WITH REFERENCE VESSEL DIAMETER OF 4.0MM AND A LESION LENGTH OF 12MM LONG. A 3.50MM X 16MM IO WAS ADVANCED. AFTER THE DEVICE PREDILATED THE TARGET LESION, STENT WAS PLACED WITH 0% RESIDUAL STENOSIS FOLLOWING POST DILATATION. THE SUBJECT WAS DISCHARGED ON CLOPIDOGREL ONE-DAY POST PROCEDURE. IN (B)(6) 2013, THE SUBJECT PRESENTED WITH CHEST PAIN, SHORTNESS OF BREATH WITH INTERMITTENT ONSET OF CHEST TIGHTNESS, AND LOWER EXTREMITY SWELLING. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED ON THE SAME DAY. AFTER ONE DAY, ELECTROCARDIOGRAM WAS PERFORMED REVEALING FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, ST DEPRESSION AND RIGHT BUNDLE BRANCH BLOCK. LATER ON THE DAY, THE SUBJECT DEVELOPED VENTRICULAR TACHYARRHYTHMIA. CARDIOPULMONARY RESUSCITATION WAS INITIATED FOR ABOUT 40 MINUTES WITH MULTIPLE SHOCKS DELIVERED TO TREAT THE ARRHYTHMIA. MEDICATION WAS GIVEN. CONTINUOUS CARDIOPULMONARY RESUSCITATION WAS PERFORMED. SUBJECT WAS INTUBATED FOR RESPIRATORY SUPPORT. DESPITE THESE AGGRESSIVE EFFORTS, A PULSE, SUSTAINABLE RHYTHM OR BLOOD PRESSURE COULD NOT BE ATTAINED. THE SUBJECT DIED WITH VENTRICULAR FIBRILLATION AS THE PRIMARY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247898 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416350 14728448

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| L