BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC?

    MDR report key: 3901079 · Received June 30, 2014

    Report

    Report Number
    2134265-2014-03696
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT : 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 2134265-2014-03695. IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY, THE LEFT COMMON FEMORAL ARTERY (CFA) AND THE RIGHT CFA. THE CHRONICALLY TOTALLY OCCLUDED (CTO) TARGET LESIONS EXTENDED FROM THE ABDOMINAL ARTERY INTO BOTH ILIAC ARTERIES. THE VASCULATURE WAS NOTED TO BE SEVERELY CALCIFIED AND SEVERELY TORTUOUS. 3 NON-BSC GUIDE WIRES CROSSED THE CTO LESIONS VIA THE PULL-THROUGH TECHNIQUE. FOR THE RIGHT LESION, THE PHYSICIAN CONFIRMED THAT THE GUIDE WIRE PASSED THROUGH NEAR THE EXTERNAL ELASTIC MEMBRANE (EEM) VIA IVUS. THE PHYSICIAN DID NOT ATTEMPT TO ADVANCE THE GUIDE WIRE AGAIN BECAUSE IT WAS ESTIMATED THAT MAKING THE GUIDE WIRE PASS THROUGH THE TRUE LUMEN WOULD BE DIFFICULT. A 6MMX40MM BALLOON CATHETER WAS ADVANCED INTO THE RIGHT LESION, THE PHYSICIAN ENCOUNTERED RESISTANCE. NO ISSUES WERE NOTED WHEN MANEUVERING THE SAME BALLOON INTO THE LEFT LESION. BOTH LESION WERE PREDILATED WITH THIS BALLOON. DUE TO THE RESISTANCE NOTED WITH THE RIGHT LESION, A LONG SHEATH WAS INSERTED FROM THE RIGHT CFA. KISSING STENT TECHNIQUE WAS USED TO DEPLOY TWO 8X120 EPIC VASCULAR STENTS AT THE SAME TIME. THE STENT IN THE LEFT LESION WAS SUCCESSFULLY DEPLOYED; HOWEVER, WHEN RELEASING THE STENT IN THE RIGHT LESION, THE DISTAL MARKER UNINTENTIONALLY MOVED TOWARD THE AORTA. THE STENT WAS RELEASED, BUT THE STENT STRUTS DID NOT STRETCH FULLY AND THE STENT WAS NOTED TO HAVE SHORTENED TO 2/3 IT'S LENGTH, POSSIBLY DUE TO RESISTANCE. TWO 8X100 EPIC VASCULAR STENTS WERE DEPLOYED; ONE IN THE LEFT LESION, ONE IN THE RIGHT. TWO 8X80 EPIC VASCULAR STENTS WERE THEN ADVANCED. ONE WAS ABLE TO BE DEPLOYED IN THE LEFT LESION; HOWEVER, STENT SHORTENING AGAIN OCCURRED IN THE RIGHT LESION DUE TO RESISTANCE. A NON-BSC STENT WAS DEPLOYED IN THE RIGHT ILIAC ARTERY. POST PROCEDURAL CT IMAGES REVEALED THE 8SX120 EPIC VASCULAR WAS COLLAPSED, APPEARED TO HAVE UNSTRETCHED STENT STRUTS AND A FLATTENED DISTAL AREA. THE 8X80 EPIC VASCULAR APPEARED TO BE TWISTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT STATUS IS GOOD. 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
    381297 EPIC? STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE UNK767

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention