BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿

    MDR report key: 2860738 · Received December 6, 2012

    Report

    Report Number
    2134265-2012-07372
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED ONLY THE STENT WAS RECEIVED. THE STENT WAS FULLY EXPANDED. DRIED BLOOD WAS PRESENT AND STRUTS ON THE DISTAL END WERE NOTED TO BE BENT. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE COMPLAINT EVENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT FEMORAL ARTERY. THE 6.0X61MM EPIC STENT SYSTEM WAS ADVANCED TO THE LESION AND DEPLOYED WITHOUT ISSUE. AFTER THE STENT WAS DEPLOYED, THE PHYSICIAN OBSERVED THE STENT WAS "KINKED". THE STENT WAS SURGICALLY REMOVED THE SAME DAY. TREATMENT OF THE ORIGINAL LESION WAS NOT COMPLETED AND THE PATIENT WILL NOT BE RESCHEDULED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT FEMORAL ARTERY. THE 6.0X61MM EPIC STENT SYSTEM WAS ADVANCED TO THE LESION AND DEPLOYED WITHOUT ISSUE. AFTER THE STENT WAS DEPLOYED, THE PHYSICIAN OBSERVED THE STENT WAS "KINKED". THE STENT WAS SURGICALLY REMOVED THE SAME DAY. TREATMENT OF THE ORIGINAL LESION WAS NOT COMPLETED AND THE PATIENT WILL NOT BE RESCHEDULED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054066070 0015029014

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention