BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC SELF-EXPANDING NITINOL VASCULAR STENT WITH DELIVERY SYS

    MDR report key: 1832066 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03969
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    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)(6); (B)(4). 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

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, STENT DEPLOYMENT DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A 70MM LONG LESION LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED , 7MM IN DIAMETER, SUPERFICIAL FEMORAL ARTERY BIFURCATION. THIS 8X72X75 EPIC VASCULAR STENT WAS USED TO TREAT THE LESION. DURING STENT DEPLOYMENT, THE STENT HAD A "BUCKLING EFFECT" AND "TOOK SHAPE OF AN ACCORDION". THE STENT DID NOT REACH ITS' FULL LENGTH. ANOTHER STENT WAS "ADDED ON TOP OF" THE EPIC STENT FOR TREATMENT. THE STENTS' WERE NOT POST-DILATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC SELF-EXPANDING NITINOL VASCULAR STENT WITH DELIVERY SYS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054087070 0012487096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention