BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 5101166 · Received September 24, 2015

    Report

    Report Number
    2183870-2015-07504
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 27, 2015
    Manufacturer
    COVIDIEN LLC
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION TO THE INITIAL MDR WITH DATE OF THIS REPORT 27-AUG-2015. THE INITIAL MDR INCORRECTLY STATED "A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT." A REVIEW OF THE MANUFACTURING RECORDS WAS NOT PERFORMED DUE TO A LOT NUMBER NOT BEING RECEIVED FROM THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    THE INDEX PROCEDURE WAS PERFORMED AS PART OF THE (B)(6) GLOBAL STUDY ON (B)(6) 2013. THE TARGET LIMB WAS ON THE LEFT SIDE. THE PROTEGE 7X80 STENT WAS DEPLOYED FOR PROVISIONAL STENTING DUE TO PERSISTENT RESIDUAL STENOSIS GREATER THAN OR EQUAL TO 50%. THERE WAS 50% RESIDUAL STENOSIS POST PROVISIONAL STENTING. ON (B)(6) 2015 INSTENT RESTENOSIS WAS REPORTED AT THE PROXIMAL EDGE OF THE TARGET LESION (LEFT SFA) WITH CRITICAL STENOSIS. THE RESTENOSIS REQUIRED IN-PATIENT HOSPITALIZATION OF 2 NIGHTS. PTA WAS PERFORMED ON THE LEFT LIMB (B)(6) 2015, WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632337 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention