BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 5951361 · Received September 14, 2016

    Report

    Report Number
    3004182619-2016-00032
    Event Type
    Death
    Date Received
    September 14, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 14, 2016
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DHR (LOT # G500DX160704A) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. THE DEVICE WAS NOT RETURNED FOR PHYSICAL INVESTIGATION. THERE WAS NO REPORTED DEVICE ISSUE. CONCLUSION: THE REPORTED EVENT WAS NOT RELATED TO DEVICE MALFUNCTION. COMPLICATIONS SUCH AS RETROPERITONEAL BLEEDING ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO ENDOVASCULAR PROCEDURES OR VASCULAR CLOSURE. IN ADDITION, THE PATIENT HAD ADDITIONAL PROCEDURES AND WAS NON-COMPLIANT AND COMBATIVE.

    Description of Event or Problem · 1

    THE VASCADE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH AND THE DISC WAS DEPLOYED. TEMPORARY HEMOSTASIS WAS ACHIEVED AND THE SHEATH WAS REMOVED. THE KEY WAS INSERTED INTO THE LOCK AND THE BLACK SLEEVE WAS RETRACTED. THE COLLAGEN WAS DEPLOYED AND FINAL HEMOSTASIS WAS ACHIEVED. IT SHOULD BE NOTED THAT PATIENT WAS NON-COMPLIANT AND COMBATIVE, BUT THE PROCEDURE WAS SUCCESSFUL AND HEMOSTASIS WAS ACHIEVED AND MAINTAINED. THE NEXT DAY, (B)(6) 2016 A PACEMAKER WAS PLACED AND THE PATIENT WAS SENT TO AN ASSISTED LIVING FACILITY. ON (B)(6) 2016, THE PATIENT CODED AT THE FACILITY AND WAS RUSHED TO THE HOSPITAL WHERE A RETROPERITONEAL BLEED WAS LOCATED. THE PATIENT WENT TO SURGERY TO REPAIR RETROPERITONEAL BLEED AND PATIENT'S CONDITION POST- SURGERY WAS FAIR. FURTHER FOLLOW UP ON (B)(6) 2016 OCCURRED AND THE CARDIVA REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601631 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-500DX G500DX160704A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death