BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1060316 · Received June 13, 2008

    Report

    Report Number
    3004939290-2008-00048
    Event Type
    Death
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVAL AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. BASED ON THE INFO PROVIDED TO ACI AND SUBSEQUENT INVESTIGATION, THE AXILLARY-FEM BYPASS WAS PERFORMED SECONDARY TO OCCLUDED STENTS, WHICH WERE DEPLOYED DURING THE 2008 PROCEDURE. THE MATERIAL OBSERVED AT THE CFA ACCESS SITE, REPORTED TO BE MYNX SEALANT, COULD NOT BE CONFIRMED BECAUSE THE SPECIMEN WAS NOT SENT TO PATHOLOGY FOR ANALYSIS. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER IFU. IT WAS REPORTED THAT THE PT HAD PVD AS WELL AS STENTS PLACED WITHIN THE VICINITY OF PUNCTURE. PER THE MYNX IFU, THE SAFETY AND EFFECTIVENESS OF THE MYNX HAVE NOT BEEN ESTABLISHED IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE PUNCTURE, OR PTS WITH PRIOR SURGICAL PROCEDURE, PTA, STENT PLACEMENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY. THE CAUSE OF DEATH, WHICH OCCURRED MORE THAN 1 WEEK LATER, IS UNK AT THIS TIME.

    Description of Event or Problem · 1

    A FEMALE PT WITH HISTORY OF PVD AND CLAUDICATION PRESENTED FOR A HEART CATH IN 2008. ACCESS WAS OBTAINED IN THE RIGHT CFA, HOWEVER, IT WAS NOTED THAT THE PT HAD SEVERE PVD INCLUDING DISEASE IN THE CFA, SFA AND PROFUNDA AS WELL AS THE ILIAC'S UP TO THE AORTA. THE PHYSICIAN PROCEEDED TO STENT THE RIGHT COMMON ILIAC UP TO THE AORTA AS WELL AS THE RIGHT CFA PROXIMAL TO THE ACCESS SITE. DESPITE THE PRESENCE OF SIGNIFICANT DISEASE, THE PHYSICIAN PROCEEDED TO USE THE MYNX DEVICE IN WHICH HEMOSTASIS WAS ACHIEVED WITHOUT IMMEDIATE COMPLICATION AND THE PT WAS DISCHARGED. APPROX 2-3 DAYS POST PROCEDURE, THE PT STARTED TO HAVE COMPLAINTS OF CLAUDICATION AND RETURNED ON SIX DAYS LATER, FOR DIAGNOSTIC ANGIOGRAPHY. ACCESS WAS OBTAINED IN THE BRACHIAL ARTERY AND ANGIOGRAPHY DOCUMENTED THAT THE STENTS PLACED ON ORIGINAL DATE WERE OCCLUDED. DURING THE PROCEDURE, THERE WERE COMPLICATIONS WITH THE BRACHIAL ACCESS THAT NECESSITATED SURGERY. AN AXILLARY-FEM BYPASS WAS PERFORMED ALONG WITH VASCULAR REPAIR AT THE BRACHIAL ACCESS SITE. THE VASCULAR SURGEON ALSO REMOVED WHAT WAS REPORTED AS MYNX SEALANT FROM THE CFA ACCESS SITE (MATERIAL WAS NOT SENT TO PATHOLOGY). THE PT REMAINED IN THE HOSP AND EXPIRED TWO WEEKS LATER, CAUSE OF DEATH IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. MX6700

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R