BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT, GDS

    MDR report key: 2963641 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00133
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    June 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K992960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO FROM THE REPORTING PHYSICIAN WAS SUBMITTED TO A CONSULTANT, A CARDIOVASCULAR CLINICAL PATHOLOGIST, FOR REVIEW AND COMMENT. BELOW IS THE CONSULTANT'S COMMENTS. "AN INFECTION WAS NOT DETECTED WITHIN THE GRAFT WALL IN THE IMAGES PROVIDED. THE FEVER AND RISE IN CRP COULD HAVE BEEN CAUSED BY AN INFECTION INDEPENDENT OF THE GRAFT, POSSIBLY DUE TO BACTEREMIA PRESENT IN THE PT PRIOR TO GRAFT IMPLANT OR FROM A WOUND INFECTION ACQUIRED AT THE TIME OF THE IMPLANT, WHICH WAS RESOLVED WITH ANTIBIOTIC THERAPY. SINCE HISTOPATHOLOGY AND CULTURE OF THE SURROUNDING TISSUE WAS NOT PERFORMED, IT CANNOT BE DETERMINED IF AN INFECTION WAS EITHER PRESENT EXTERNAL TO THE GRAFT OR A CONTRIBUTOR TO THE OBSERVED FLUID BUILDUP. IT IS ALSO POSSIBLE THAT CLAMP DAMAGE TO THE NATIVE VESSEL ANASTOMOTIC LOCATIONS RESULTED IN FLUID EXUDATE THAT WOULD NOT TEST POSITIVE FOR INFECTION. TISSUE INGROWTH IS A FUNCTION OF HEALING RESPONSE WHICH WILL VERY DEPENDING ON PT BIOLOGY AND DISEASE STATE AND TIME. GIVEN THE COMPROMISED HEALTH OF THIS PT, WITH A SUSPECTED SYSTEMIC INFECTION AND RELATIVELY SHORT TIME FRAME (2 WEEKS) BETWEEN IMPLANT AND EXPLANT IN THE CASE THE LACK OF ADVENTITIAL INGROWTH IS NOT OUT OF THE ORDINARY. IT WAS ALSO NOTED THAT THE CLOT SHOWN IN THE IMAGES IS CHARACTERISTIC OF THAT FORMED POST MORTEM AND NOT INDICATIVE OF THROMBUS WITHIN THE GRAFT. ALL OF THE MFG CRITERIA WERE MET AND QUALITY CONTROL RECORDS VERIFY THAT ALL TESTING WAS WITHIN SPECIFICATION."

    Description of Event or Problem · 1

    A LEFT FEMORAL - ABOVE KNEE BYPASS GRAFT WAS PERFORMED ON (B)(6) 2008. AFTER THE GRAFT WAS IMPLANTED, PT HAD A RECURRENT FEVER (37C/98.6 DEGREES FAHRENHEIT - 38.8C/101.8 DEGREES FAHRENHEIT) AND RISE IN C-REACTIVE PROTEIN FOR TWO WEEKS, HOWEVER; NO ELEVATED WHITE BLOOD CELL WAS SEEN. EVENTUALLY, THE GRAFT WAS REMOVED ON (B)(6) SINCE THE GRAFT SUSPECTED INFECTION. THE PHYSICIAN SAID THAT THE GRAFT WAS EASILY REMOVED (AUTOGENOUS HEALING WAS NOT SEEN) AND THERE WERE SMALL AMOUNT OF FAINT YELLOW FLUID AT BOTH PROXIMAL AND DISTAL ANASTOMOSIS SITES (NOT PERIGRAFT). THE GRAFT, BLOOD AND FLUID WERE SENT TO A LAB FOR CULTURE, HOWEVER, NO INFECTION WAS CONFIRMED. THE FEVER WAS BROKEN AND CRP VALUE WAS NORMALIZED AFTER GRAFT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371 ADVANTA VXT, GDS DSY ATRIUM MEDICAL CORP. 22213 AG19808

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention BEFORE OPERATION - UNASYN-S| INTRAVENOUS DOSAGE: 1.5G (5PM)| TX DATE: (B)(6) 2008 - CIPROXIN (CIPROFLOXACIN)| INTRAVENOUS DOSAGE: 0.5G (10 A.M. & 8 P.M.)| THE GRAFT DURING OPERATION AND AFTER IMPLANTATION.| DOSAGE: 0.5G (1 A.M.)| TX DATE: (B)(6) 2008 - MEROPEN| ANTIBIOTICS SOLUTIONS WERE NOT FLUSHED THROUGH| DOSAGE: 0.5G (6 A.M.)| INTRAVENOUS DOSAGE: 1.5G (2 A.M., 10 A.M, & 8 P.M)| (SODIUM SULBACTAM SODIUM AMPICILLIN)| UNASYN-S (SODIUM SULBACTAM SODIUM AMPICILLIN)| (MEROPENEM HYDRATE)| INTRAVENOUS DOSAGE: 0.3G (2 DOSE/DAY)| MEROPEN (MEROPENEM HYDRATE) INTRAVENOUS| MEROPEN (MEROPENEM HYDRATE) INTRAVENOUS