BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2992468 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01553
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 26, 2012
    Report Date
    February 8, 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. PATIENT IDENTIFIER: (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) STUDY. SAME PATIENT AS MDR ID# 265-2013-00752 AND 2134265-2013-00753. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, VESSEL OCCLUSION OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED A 100% STENOSED, TOTALLY OCCLUDED, DE NOVO LONG LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) ARTERY EXTENDING TO MID LAD. THE LESION WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM AND TREATED WITH PRE-DILATATION AND THE PLACEMENT OF A 2.50 MM X 20 MM (B)(4) STUDY STENT AND A 2.75 MM X 16 MM (B)(4) STUDY STENT WITH 0% RESIDUAL STENOSIS. POST DEPLOYMENT OF THE 2.50 MM X 20 MM (B)(4) STUDY STENT, THERE WAS AN OCCLUSION OF SMALL DIAGONAL BRANCH. AN ATTEMPT WAS MADE TO REWIRE THIS DIAGONAL BRANCH BUT WAS UNSUCCESSFUL DUE TO THE VERY SMALL VESSEL DIAMETER. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98307 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420250 14394885

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention