BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3233107 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-05395
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE A 2.5 MM X 28MM ION NON-STUDY STENT WAS PLACED IN THE PROXIMAL SVG TO DISTAL RCA. IN (B)(6) 2013, THE SUBJECT PRESENTED DUE TO CHEST DISCOMFORT AND DYSPNEA ON EXERTION.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID: 2134265-2013-05395. SAME PATIENT AS MDR ID: 2134265-2013-04876. IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION UNSTABLE ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED AND WAS ENROLLED IN THE (B)(4). TARGET LESION #1 WAS LOCATED IN THE DISTAL SAPHENOUS VEIN GRAFT TO DISTAL RIGHT CORONARY ARTERY WITH 99% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 20 MM. AFTER THE PLACEMENT OF THE 2.50 MM X 20 MM ION US COA STUDY STENT IN THE LESION, THERE WAS "WORSENING AT THE OSTIUM AT ABOUT 20 MM LENGTH OF THE VEIN GRAFT AS WELL AS SOME WORSENING JUST PROXIMAL TO THAT" FOR WHICH INTRACORONARY NITROGLYCERINE WAS GIVEN, NO CHANGE OCCURRED. SUBSEQUENTLY A 2.5 MM X 28 MM ION STENT WAS PLACED AT THE OSTIUM OF THE RIGHT CORONARY ARTERY. EVEN AFTER THE CONTINUOUS NITRATES ADMINISTRATION, A SIGNIFICANT STENOSIS OR NARROWING WAS DEMONSTRATED JUST PROXIMAL TO THE FIRST STUDY STENT (2.50 MM X 20 MM) WHICH WAS TREATED WITH THE PLACEMENT OF 2.50 MM X 12 MM ION US COA STUDY STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. AFTER THE PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN JUNE 2013, 90% FOCAL STENOSIS IN THE SVG TO PROXIMAL RIGHT CORONARY ARTERY WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 8 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. IN ADDITION, A 70% DIFFUSE RESTENOSIS AT THE DISTAL STENT EDGES OF THE SAPHENOUS VEIN GRAFT TO DISTAL RIGHT CORONARY ARTERY WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2.75 MM X 38 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. ON THE NEXT DAY, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333406 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902420250 14561958

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention