BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1040874 · Received May 7, 2008

    Report

    Report Number
    3004939290-2008-00028
    Event Type
    Death
    Date Received
    May 7, 2008
    Date of Event
    April 4, 2008
    Report Date
    May 6, 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

    THE DEVICE WAS NOT RETURNED TO ACT FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THERE IS NO EVIDENCE THAT INDICATES THE DEVICE DID NOT MEET SPECIFICATION AND THAT IT DID NOT PERFORM IN ACCORDANCE WITH ITS SPECIFICATIONS AND THE IFU. THE CAUSE OF DEATH WAS REPORTED AS A RETROPERITONEAL BLEED, WHICH WAS BASED ON THE COURSE OF EVENTS LEADING TO THE PT'S DEATH. AUTOPSY REPORT AND OTHER SOURCE DOCUMENTS HAVE BEEN REQUESTED, BUT NOT YET RECEIVED. IN CONSIDERING POTENTIAL CAUSES OF THE ASSUMED RETROPERITONEAL BLEED, IT WAS MOST LIKELY DUE TO THE REPORTED HIGH STICK ALONG WITH A HIGH ACT AT MYNX DEPLOYMENT. PER THE MYNX IFU, DO NOT USE THE MYNX VASCULAR CLOSURE DEVICE IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED.

    Description of Event or Problem · 1

    FEMALE PT WITH HISTORY OF HYPERTENSION WAS TRANSFERRED EMERGENTLY TO THE HOSPITAL WITH EKG CHANGES SUGGESTIVE OF AN ACUTE MI IN 2008. THE PT WAS TAKEN DIRECTLY TO THE CARDIAC CATH LAB ON AN IV HEPARIN DRIP AND CORONARY INTERVENTION WAS PERFORMED. A FEMORAL ANGIOGRAM WAS PERFORMED PRIOR TO DEPLOYMENT OF THE MYNX DEVICE, IN WHICH IT WAS REPORTED BY THE PHYSICIAN THAT THE ACCESS SITE PUNCTURE WAS A HIGH STICK. THE MYNX DEVICE WAS SUCCESSFULLY DEPLOYED AND HEMOSTASIS ACHIEVED BY A FULLY-TRAINED CATH LAB TECHNICIAN. POST PROCEDURE ACT WAS 420 SEC, AND A FEMSTOP WAS PROPHYLACTICALLY APPLIED PER CATH LAB STANDARD OF CARE. THE PT WAS REPORTEDLY TRANSFERRED TO THE NURSING FLOOR IN STABLE CONDITION, HOWEVER, HER BLOOD PRESSURE STARTED DROPPING SHORTLY THEREAFTER. THERE WERE NO OBVIOUS SIGNS OF BLEEDING OR HEMATOMA NOTED. HER CONDITION CONTINUED DETERIORATING AND THE PT SUBSEQUENTLY EXPIRED THAT SAME DAY, DUE TO WHAT WAS BELIEVED TO BE A RETROPERITONEAL BLEED BASED ON THE COURSE OF EVENTS LEADING TO THE PT'S DEATH (NO REPORT OF CT PERFORMED). TO DATE, THE AUTOPSY REPORT AND OTHER SOURCE DATA CONFIRMING CAUSE OF DEATH IS PENDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death PERI-PROCEDURAL MEDS INCLUDED HEPARIN