BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM

    MDR report key: 3884862 · Received June 19, 2014

    Report

    Report Number
    2183870-2014-00144
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    August 5, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K050725
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    EVALUATION SUMNMARY: THE PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM WAS RECEIVED FOR EVALUATION WITHOUT ANY ANCILLARY DEVICES OR CINE IMAGES FROM THE PROCEDURE. THE PROTEGE GPS STENT DELIVERY SYSTEM, (SDS), WAS RETURN LOOSE, NESTED INSIDE SEVERAL BAGS. THE SDS DEPLOYMENT PADDLES WERE APPROXIMATELY 35MM DISTANT FROM EACH OTHER, THE SAFETY LOCKING PIN WAS LOOSE, AND THE MANIFOLD TO OUTER SHEATH BOND WAS FULLY COMPROMISED. DRY CRYSTALLINE SANGUINE MATERIAL WAS NOTED ON THE OUTER SHEATH OF THE SDS. THE STRAIN RELIEF WAS REMOVED TO ALLOW EXAMINATION OF THE MANIFOLD TO OUTER SHEATH BOND FILLET. USING BACKLIGHTING, THE LOCATION OF THE RETAINER WAS FOUND TO BE APPROXIMATELY 261MM PROXIMAL OF THE DISTAL END OF THE DISTAL MARKER BAND. THE STENT LENGTH ASSOCIATED WITH THIS DEVICE WAS 150MM. THE INNER GUIDEWIRE LUMEN EXHIBITED STRETCHING. THE OUTER SHEATH WAS PULLED PROXIMAL WITH EASE TO EXPOSE THE RETAINER. THE INNER GUIDEWIRE LUMEN EXHIBITED ACCORDION FOLDING JUST DISTAL TO THE RETAINER. A MASS OF BIOLOGICAL MATERIAL ENCOMPASSED THE INNER AT THE POSITION THE OUTER SHEATH WAS WHEN THE SDS WAS RETURNED.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6): WHILE DEPLOYING THE PROTEGE STENT, ONLY THE FIRST HALF DEPLOYED. THE REST OF THE STENT REMAINED IN THE DEPLOYMENT SYSTEM. THE DOCTOR DETACHED THE HANDLE FROM THE SHAFT AND APPLIED EXTRA FORCE TO WITHDRAW THE DELIVERY SYSTEM, WHICH THEN DEPLOYED THE REST OF THE STENT IN AN ELONGATED MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359871 PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN SERB65-08-150-120 9785425

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R