BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION¿

    MDR report key: 2971884 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00752
    Event Type
    Death
    Date Received
    February 21, 2013
    Date of Event
    September 2, 2012
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER: 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS MDR ID# 2134265-2013-00753. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, PATIENT DEATH OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED DUE TO SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED A 100% STENOSED, TOTALLY OCCLUDED, LONG DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO THE MID LAD. A PT GRAPHIX WIRE TO THE DISTAL LAD, HOWEVER, IT WOULD NOT CROSS THE OCCLUSION. THE OCCLUSION WAS SUCCESSFULLY CROSSED WITH A NON-BSC WIRE. THE LESION WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM AND WAS TREATED WITH PRE-DILATATION AND THE PLACEMENT OF TWO ION STUDY STENTS (2.50 X 20MM AND 2.75 X 16MM) WITH 0% RESIDUAL STENOSIS. IN ADDITION, POST DEPLOYMENT OF STENT . POST DEPLOYMENT OF THE 2.50 X 20MM ION STENT, THERE WAS AN OCCLUSION OF SMALL DIAGONAL BRANCH. AN ATTEMPT WAS MADE TO REWIRE THIS DIAGONAL BRANCH WHICH WAS UNSUCCESSFUL DUE TO VERY SMALL VESSEL DIAMETER. THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE SUBJECT DIED. THE CAUSE OF DEATH WAS PROBABLE ACUTE MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76997 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420250 14394885

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death GUDIEWIRE: PT GRAPHIX