BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION?

    MDR report key: 3052957 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02315
    Event Type
    Death
    Date Received
    April 11, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 14, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME, THE TWO ION STENTS WERE PLACED IN THE RIGHT POSTERIOR DESCENDING ARTERY (PDA) AND DISTAL RIGHT CORONARY ARTERY (RCA) RESULTING IN 0% RESIDUAL STENOSIS AND TIMI III FLOW. PATIENT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT WAS FOUND DOWN, HYPOTENSIVE, AND WITH A FEVER. UPON ARRIVAL TO THE EMERGENCY DEPARTMENT THE PATIENT WAS UNRESPONSIVE, BRADYCARDIC, AND WITHOUT A PULSE. CPR WAS INITIATED, HOWEVER PATIENT DID NOT RESPOND TO RESUSCITATIVE EFFORTS AND EXPIRED.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MFR ID # 2134265-2013-02266. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, PATIENT DEATH OCCURED. THE 3.0X12MM ION AND 2.5X12MM ION STENTS WERE IMPLANTED. IN (B)(6) 2013, 591 DAYS POST INDEX PROCEDURE THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156124 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902412250 13978435

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death