BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION?

    MDR report key: 3419262 · Received October 18, 2013

    Report

    Report Number
    2134265-2013-07289
    Event Type
    Death
    Date Received
    October 18, 2013
    Date of Event
    September 20, 2013
    Report Date
    September 23, 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

    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).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASSIFICATION 1) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DE NOVO TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 80% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00X38 MM ION STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT WHO WAS A NURSING HOME RESIDENT PRESENTED IN ASYSTOLE, ABSENT PULSE AND SPONTANEOUS RESPIRATION. EMERGENCY MEDICAL SERVICES WERE CALLED, WHO INSTITUTED ADVANCED CARDIAC LIFE SUPPORT (ACLS) PROTOCOLS, BUT WERE UNABLE TO OBTAIN IV ACCESS OR AIRWAY PRIOR TO ARRIVING AT ER. THE PATIENT WAS SHIFTED TO ER WHERE HE WAS INTUBATED AND IO ACCESS WAS OBTAINED WITH LEFT LOWER EXTREMITY. THE PATIENT WAS ASYSTOLE THROUGHOUT. ACSL PROTOCOLS INCLUDING CHEST COMPRESSIONS, BAG-VALVE-MASK VENTILATION AND EPINEPHRINE WERE CONTINUED EVERY 5 MINUTES. THE PATIENT REMAINED ASYSTOLE AND RESUSCITATIVE MEASURES WERE TERMINATED. THE PATIENT DIED AND THE CAUSE OF DEATH WAS SUDDEN CARDIAC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535946 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902438300 14868909

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death