BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3890207 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03947
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    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

    (B)(4).

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

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-03948, 2134265-2014-04073. (B)(4). IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS OCCURED. IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A IN-STENT RESTENOSIS LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 35 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 MM X 38 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A IN-STENT RESTENOSIS LOCATED IN THE PROXIMAL RCA WITH 90% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 MM X 24 MM ION¿STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND WAS HOSPITALIZED. DURING TARGET VESSEL REVASCULARIZATION (TVR), THE 70% RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENTS IN THE PROXIMAL TO MID RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3.00 MM X 38 MM AND 3.50 MM X 20 MM PROMUS PREMIER DRUG ELUTING STENTS, IN OVERLAPPING MANNER, WITH 0% RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESIONS DURING THE INDEX PROCEDURE, WERE IN-STENT RESTENOSIS OF TWO UNKNOWN DRUG ELUTING STENTS IN MID AND PROXIMAL RCA. IN (B)(6) 2014, THE PATIENT WAS SEEN FOR CHEST PAIN. THE RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENTS WERE DIFFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369196 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902438300 14512364

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R