BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®GPS¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 3223634 · Received July 12, 2013

    Report

    Report Number
    2183870-2013-00170
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 13, 2013
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    PMA / PMN Number
    K050725
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 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.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6):THE CUSTOMER STATED THAT WHEN THE STENT WAS DEPLOYED, THE OUTER SHEATH WITHDREW COMPLETELY, BUT ONLY HALF OF THE STENT WAS DEPLOYED. THE STENT AND PART OF THE INNER SHEATH WERE BROKEN. THE PATIENT WAS NOT INJURED BUT MEDICAL INTERVENTION WAS REQUIRED; SURGERY WAS EXTENDED BY MORE THAN 30MINS. THE HALF OF THE STENT THAT WAS DEPLOYED IN THE PATIENT'S BODY WAS COVERED WITH AN ADDITIONAL STENT.

    Description of Event or Problem · 1

    PICTURE AND CINE EVALUATION: TWO PICTURES AND TWO CINE IMAGES FROM THE PROCEDURE WERE USED FOR THE INVESTIGATION. IN CINE 1 THE STENT DELIVERY SYSTEM (SDS) IS VISIBLE AND IN A STATE OF BEING DEPLOYED. THE STENT FRACTURE IS EVIDENT WITH THE PROXIMAL END OF THE STENT FRACTURE IN A FLOWERED STATE AND THE DISTAL END OF THE STENT FRACTURE IN A DEPLOYED STATE. IN PHOTO 1 THE SDS HAS BEEN REMOVED FROM THE BODY. THE PROXIMAL END OF THE STENT FRACTURE IS IN A FLOWERED STATE ATTACHED TO THE SDS. IN PHOTO 2 THE DISTAL TIP OF THE SDS HAS BEEN RECOVERED AND IS OUTSIDE THE BODY. THE DISTAL TIP AND TUBE OF THE SDS ARE FRACTURED DISTAL TO THE PROXIMAL RETAINER OF THE SDS. IN CINE 2 A SECOND STENT HAS BEEN DEPLOYED AND CLEARLY SHOWS THAT THE DISTAL SIDE OF FRACTURE STENT IS CONTAINED UNDER ANOTHER STENT IN THE PATIENTS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324535 PROTÉGÉ ®GPS¿ SELF EXPANDING PERIPHERAL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. SERP65-08-60-120 9712619

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention