BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿

    MDR report key: 2780913 · Received October 10, 2012

    Report

    Report Number
    2134265-2012-06311
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    July 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2012-06309, 2134265-2012-06310. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CALF PAIN. LESION 1 WAS LOCATED IN THE PROXIMAL LEFT COMMON ILIAC ARTERY (CIA). THE LESION WAS 100% STENOSED, 8.0MM IN DIAMETER, 80MM LONG AND WAS CLASSIFIED AS A TASC C LESION. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 8X100MM STUDY STENT. DUE TO FORESHORTENING, AN 8X60MM BAILOUT STUDY STENT WAS PLACED. AFTER POST-DEPLOYMENT DILATION, THERE WAS 0% RESIDUAL STENOSIS. LESION 2 WAS LOCATED IN THE PROXIMAL RIGHT CIA. THE LESION WAS 100% STENOSED, 8.0MM IN DIAMETER, 10MM LONG AND WAS CLASSIFIED AS A TASC C LESION. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 9X60MM STUDY STENT. POST-DEPLOYMENT DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 10%. PRE-DISCHARGE ASSESSMENT WAS RUTHERFORD CATEGORY 2, RIGHT ABI 0.88, AND LEFT ABI 0.62. THE PATIENT WAS TREATED AS AN OUTPATIENT AND RELEASED ON ASPIRIN THERAPY. IN (B)(6) 2012, THE PATIENT EXPERIENCED CALF PAIN. IN (B)(6) 2012, A DUPLEX ULTRASOUND WAS PERFORMED. NO ACTION WAS REPORTED TO BE TAKEN FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED POST A PERIPHERAL STENTING TREATMENT PROCEDURE, NOT A CORONARY STENTING TREATMENT PROCEDURE AS PREVIOUSLY REPORTED. (B)(6) 2012 THE PATIENT UNDERWENT A BALLOON ANGIOPLASTY OF AN 80% STENOSIS IN THE STUDY STENT IN THE RIGHT CIA. AN EPIC STENT WAS PLACED IN THE RIGHT EIA. THERE WAS PROGRESSION OF DISEASE IN THE NATIVE LEFT EIA AND LEFT COMMON FEMORAL ARTERY (CFA) OUT OF THE ZONE OF THE PRIOR ORION STENTS IN THE LEFT CIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939141096070 12386547

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other