BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLX

    MDR report key: 4851341 · Received June 17, 2015

    Report

    Report Number
    2183870-2015-00218
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 18, 2015
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    K110023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4), FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4)

    Description of Event or Problem · 1

    THIS SFA RECANALISATION PROCEDURE WAS PERFORMED IN (B)(6). THE PATIENT IS AN (B)(6) YEAR OLD FEMALE,WITH A CALCIFIED SFA LESION. THE PROTEGE EVERFLEX 6X100X120 WAS IMPLANTED AFTER PTA BALLOON INFLATION. THE PROTEGE EVERFLEX STENT HANDLE WAS CHECKED, AND THE STENT WAS PREPARED. THE PHYSICIAN BEGAN TO DEPLOY THE STENT. VIEWING THE DEPLOYMENT ON THE SCREEN THE PHYSICIAN NOTICED THAT PART OF THE STENT WAS STILL IN THE SHEATH, NOT DEPLOYED. THE ONLY OPTION WAS TO PULL THE SHEATH WHICH MADE THE STENT ELONGATE AND DEFORM. ANOTHER EVERFLEX STENT WAS PLACED WITHIN THIS STENT. GOOD FLOW IS NOW MAINTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395238 PROTEGE EVERFLX STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN PRP35-06100120V01 A023824

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention