BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1738654 · Received June 28, 2010

    Report

    Report Number
    2031527-2010-00079
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 24, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. INTRAOPERATIVE BALLOON OVERINFLATION CAUSED DISSECTION IN THE AORTA. USE OF DEVICE IN SHORT AORTIC NECK LENGTH AND BILATERAL PERCUTANEOUS ACCESS FOR THIS CASE IS OFF-LABEL PER INDICATIONS FOR USE.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE A SHORT REVERSE CONICAL AORTIC NECK (OFF-LABEL), A LARGER 6.5CM DISTAL ANEURYSM AND A SMALLER 3.4CM PROXIMAL ANEURYSM WITH NON-ANEURYSMAL AORTA BETWEEN. THE PHYSICIAN USED A BILATERAL PERCUTANEOUS APPROACH (OFF-LABEL). PATIENT PRESENTED WITH A SINGLE (RIGHT) KIDNEY SO THE PHYSICIAN CANNULATED BRACHIALLY IN AN EFFORT TO PROTECT IT. ON (B) (6) 2010, PATIENT IMPLANT OF A BIFURCATED DEVICE 28-16-120BL AND A 34-34-100RLE WITH A PRE-PLANNED AORTIC STENT. THE AORTIC STENT MOVED DOWN APPROXIMATELY 6CM. A SECOND AORTIC STENT WAS USED WHICH MOVED DOWN APPROXIMATELY 4CM. THE PHYSICIAN BALLOONED PROXIMALLY IN AN ATTEMPT TO RESOLVE A TYPE I ENDOLEAK. A FINAL ANGIOGRAM WAS TAKEN AND IT WAS NOTED THERE WAS EXTRAVASATION OF THE PROXIMAL AORTA DUE TO BALLOON OVERINFLATION. THE PATIENT WAS CLOSED BECAUSE THE PHYSICIAN THOUGHT THE EXTRAVASATION WAS NOT SIGNIFICANT. WHEN THE PHYSICIAN REMOVED THE SHEATH FROM THE BRACHIAL ARTERY, IT WAS NOTED THAT THE HAND WAS BLUE W/ NO PULSES. THE ARM WAS OPENED TO RESOLVE THE DISSECTION. POST-IMPLANT APPROXIMATELY 3 HOURS LATER, THE PATIENT COMPLAINED OF BACK PAIN PRESSURE AND HER HEMATOCRIT DROPPED; AT THIS POINT THE PATIENT WAS NOT DISCHARGED. THE PHYSICIAN CONVERTED TO OPEN REPAIR AND FOUND NO SIGNIFICANT HEMATOMA. THE DEVICES WERE EXPLANTED AND THE PHYSICIAN PLACED A TUBE GRAFT. THIS PROCEDURE LASTED APPROXIMATELY 2 HOURS. THE CROSS CLAMP ON THE AORTA WAS REMOVED AND THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN REPORTED THAT THE PATIENT DIED OF HYPOTENSION, CARDIAC FAILURE, AND RUPTURED AAA. THE EXPLANTED STENT GRAFTS WERE NOT AVAILABLE; THE PATIENT HAD HEPATITIS C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 34-34-100RLE W09-3655-012

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R