BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI

    MDR report key: 6123145 · Received November 22, 2016

    Report

    Report Number
    2126666-2016-00091
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 22, 2016
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K130798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. REVIEW OF THE DFU NOTES THE REPORTED EVENT AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. THE COMPLAINT NARRATIVE DID NOT NOTE THAT THE SAFARI GUIDEWIRE CAUSED OR CONTRIBUTED TO THIS INCIDENT, HOWEVER, BECAUSE THE SAFARI GUIDEWIRE WAS ONE OF THE DEVICES USED IN THE PROCEDURE, A MEDWATCH REPORT IS BEING FILED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED; HOWEVER, IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH WILL BE FILED. PRODUCT WAS DISPOSED OF BY END USER.

    Description of Event or Problem · 1

    ABDOMINAL AORTA DISSECTION DURING THE INTRODUCTION OF THE LOTUS EDGE VALVE. THE PATIENT HAD SUCH OVERWEIGHT THAT IN THE AP VIEW THE PHYSICIAN COULD NOT VIEW THE SAPPHIRE WIRE AND THE INTRODUCER AND LOTUS EDGE VALVE AT THE SAME TIME. THE DISSECTION WAS REPAIRED WITH ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND A NEW LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED 27MM. THE PATIENT DID NOT RECOVER FROM THIS AND EVENTUALLY DIED. WHERE THE DISSECTION OCCURRED THEY DID SUBSEQUENTLY FIND A PREEXISTING AORTIC ANEURYSM. THE SAPPHIRE WIRE AND THE LOTUS INTRODUCER WAS ACCIDENTLY DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772987 PREFORM GUIDEWIRE - SAFARI WIRE GUIDE DQX LAKE REGION MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death