BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 2960139 · Received February 13, 2013

    Report

    Report Number
    2031527-2013-00022
    Event Type
    Death
    Date Received
    February 13, 2013
    Date of Event
    October 27, 2012
    Report Date
    January 15, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, OPERATIVE NOTES FROM THE INDEX PROCEDURE, PROCEDURE PLANNING SHEET, MULTIPLE PROGRESS NOTES AND THE DISCHARGE SUMMARY WERE PROVIDED BY THE HOSPITAL. BASED UPON THE REVIEW OF THE MEDICAL RECORDS BY CLINICAL REPRESENTATIVE THE PATIENT HAD A DELAYED TYPE I ENDOLEAK PRESENT AT THE CONCLUSION OF THE PROCEDURE, WHERE BOTH THE AORTIC EXTENSIONS WERE VIGOROUSLY BALLOONED IN AN ATTEMPT TO RESOLVE THE ENDOLEAK. PATIENT ANATOMY (OFF-LABEL), VIGOROUS BALLOONING MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING SUCCESSFUL IMPLANTATION OF A BIFURCATED DEVICE, INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION, A PROXIMAL TYPE I ENDOLEAK WAS NOTED. BOTH THE AORTIC EXTENSIONS WERE VIGOROUSLY BALLOONED IN AN ATTEMPT TO RESOLVE THE NOTED TYPE I ENDOLEAK. THE ENTIRE GRAFT AND THE ILIACS WERE BALLOONED AS WELL, BUT THE ENDOLEAK PERSISTED. THE PHYSICIAN ELECTED NOT TO PLACE ANOTHER EXTENSION DUE TO THE PATIENT'S ANATOMY AND OTHER COMORBIDITIES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. REPORTEDLY, TWO DAYS POST-IMPLANT THE PATIENT WAS FOUND TO BE PALE, APNEIC AND UNRESPONSIVE. CPR WAS ADMINISTERED AND THE PATIENT REGAINED A PULSE AND RHYTHM. AT THIS TIME, PATIENT'S ABDOMEN WAS NOTED TO BE DISTENDED. THERE WAS CONSIDERATION OF PERFORMING A COMPUTED TOMOGRAPHY ANGIOGRAM TO RULE OUT PULMONARY EMBOLISM AND TO ASSESS THE ABDOMINAL DISTENTION. THE PATIENT'S BLOOD WORK SHOWED DROP IN HEMATOCRIT, SUGGESTING THAT THE CAUSE WAS BLEEDING FROM AORTA OR ONE OF THE ILIAC VESSELS. SURGICAL INTERVENTION WAS DENIED BY PROXY. DEATH CERTIFICATE INDICATED THE CAUSE OF DEATH WAS DUE TO HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63770 AFX SYSTEM SUPRARENAL AORTIC EXTENSION MIH ENDOLOGIX, INC. A34-34/C100-O20 W11-4432R-027

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death