BEUDAMED
    FDA Adverse Event Death Summary report: N

    UVAR XTS

    MDR report key: 963057 · Received December 11, 2007

    Report

    Report Number
    2523595-2007-00014
    Event Type
    Death
    Date Received
    December 11, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 24, 2007
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE OF THE PROPENSITY OF HER CENTRAL VENOUS CATHETER TO CLOT DURING PHOTOPHERESIS PROCEDURES, THIS PATIENT RECEIVED TISSUE PLASMINOGEN ACTIVATOR (T-PA) DIRECTLY INTO THE CENTRAL VENOUS CATHETER IN ORDER TO PREVENT CATHETER THROMBOSIS. THE ADMINISTRATION OF T-PA OR ANY OTHER THROMBOLYTIC THERAPY IS NOT CONTAINED IN THE THERAKOS PHOTOPHERESIS OPERATORS' MANUAL. THE USE OF HEPARIN IS REQUIRED FOR ANTICOAGULATION DURING THE PHOTOPHERESIS THERAPY.

    Description of Event or Problem · 1

    A FEMALE HAD A DIAGNOSIS OF CHRONIC GRAFT-VERSUS-HOST DISEASE WITH CUTANEOUS AND HEPATIC MANIFESTATIONS. THE PATIENT HAD UNDERGONE A PRIOR MATCHED UNRELATED DONOR TRANSPLANT APPROXIMATELY 4.5 YEARS AGO FOR THE TREATMENT OF MYELODYSPLASTIC SYNDROME AND REFRACTORY ANEMIA. THE PATIENT HAD BEEN TREATED WITH CORTICOSTEROIDS AND CALCINEURIN INHIBITORS FOR CHRONIC GVHD AND HAD RECEIVED APPROXIMATELY 45-47 PRIOR ECP TREATMENTS BEFORE THE ECP PROCEDURE IN QUESTION IN 2007. THE PATIENT HAD BEEN RECEIVING ECP TREATMENTS THROUGH A VORTEX PORT-A-CATH, WHICH HAD PREVIOUSLY EXHIBITED A PROPENSITY TO THROMBOSE DURING AND AFTER ECP PROCEDURES. AS A RESULT, ECP OPERATORS TREATING THE PATIENT HAD HISTORICALLY INCREASED THE PATIENT'S HEPARIN DOSE BY APPROXIMATELY 20% AND HAD INSTILLED 2 MILLIGRAMS OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) INTO THE CENTRAL VENOUS CATHETER BETWEEN BACK-TO-BACK CONSECUTIVE DAY ECP TREATMENTS. THE HEPARIN PRODUCT USED ON THE ECP PROCEDURE OF INTEREST WAS MANUFACTURED BY ABRAXIS PHARMACEUTICAL PRODUCTS (LOT #404214; EXPIRATION DATE: 07/2009). THE ECP PROCEDURE ON THE DAY IN QUESTION WAS A LONG PROCEDURE WITH HIGHER THAN AVERAGE TOTAL INFUSED VOLUME OF 343 ML (OVER THE COURSE OF A 3 HR, 25 MINUTE PROCEDURE). THAT ANTICOAGULANT VOLUME TRANSLATED INTO 8,232 UNITS OF UNFRACTIONATED HEPARIN ADMINISTERED TO THE PATIENT. ON THE SAME DAY, THE PATIENT HAD AN UNEVENTFUL ECP PROCEDURE THAT WAS CONCLUDED (THE FIRST OF TWO CONSECUTIVE DAY PROCEDURES) AT APPROXIMATELY 1400-1415 HRS. THE PRE-ECP HEMATOCRIT WAS 36%, THE PLATELET COUNT WAS 142,000/CMM AND THE TOTAL LEUKOCYTE COUNT WAS REPORTED AS WITHIN NORMAL LIMITS. THE BLOOD UREA NITROGEN AND CREATININE WERE 29 AND 1.0 MG% RESPECTIVELY. LIVER FUNCTION TESTS WERE REPORTED AS MILDLY CHRONICALLY ELEVATED (PRESUMPTIVELY DUE TO CHRONIC GVHD) WITHOUT ANY NOTABLE CHANGE. BLOOD PRESSURES DURING THE PROCEDURE VARIED BETWEEN 120-130/60-70. NO POST-ECP BLOODWORK WAS OBTAINED. THE PATIENT COMPLAINED OF NO SYMPTOMS DURING OR AFTER THE ECP PROCEDURE AND WAS EXAMINED DURING THE PROCEDURE BY HER CLINIC PHYSICIAN WHO REPORTED THAT THE PATIENT APPEARED WELL. THE PATIENT'S CAREGIVER ARRIVED AND DROVE THE PATIENT HOME AT 1500 HRS. SHORTLY THEREAFTER, THE PATIENT DEPARTED ON HER OWN TO THE BANK FOR AN ERRAND. AT APPROXIMATELY 1730 HRS, THE PATIENT WAS FOUND DOWN ON THE SIDEWALK OUTSIDE OF THE BANK AND PARAMEDICAL PERSONNEL WERE SUMMONED. SHE WAS URGENTLY TRANSPORTED TO A LOCAL HOSPITAL AND EVALUATED AFTER ARRIVAL AT 1815 HRS. THE INITIAL EXAMINATION DEMONSTRATED THAT THE PATIENT WAS CONSCIOUS BUT HAD A LEFT HEMIPARESIS. THE PROTHROMBIN AND PARTIAL THROMBOPLASTIN TIMES WERE REPORTED TO BE NORMAL IN THE EMERGENCY ROOM AND THE PLATELET COUNT WAS 120,000/CMM. A COMPUTED TOMOGRAPHIC EXAMINATION FO THE HEAD REVEALED TWO LARGE INTRACEREBRAL HEMATOMAS IN THE FRONTAL AND FRONTO-PARIETAL REGIONS. IT IS UNKNOWN IF THE PATIENT WAS COMPLAINING OF SYMPTOMS REFERABLE TO THE HEAD AT THAT TIME. DURING AN EVALUATION BY A NEUROSURGEON, THE PATIENT LOST CONSCIOUSNESS AND DEVELOPED DECEREBRATE POSTURING. AN URGENT OPERATIVE EXPLORATORY RIGHT CRANIOTOMY WAS PERFORMED. AFTER LIFTING THE OSTEOTOMY FLAP AND DIVISION OF THE MENINGES (WHICH WERE NOT SPONTANEOUSLY PULSATING), THE LARGER FRONTO-PARIETAL HEMATOMA SPONTANEOUSLY DRAINED INTO THE SURGICAL FIELD. THE FLUID APPEARED TO BE A MIXTURE OF BLOOD AND SEROSANGUINOUS FLUID SUGGESTIVE OF FLUID FROM A CYSTIC CAVITY. HOWEVER, INTRAOPERATIVE EVALUATION OF THE FLUID REVEALED ONLY THROMBUS WITHOUT ANY TUMOR FORMATION. A SECONDARY INCISION IN THE MOTOR CORTEX DRAINED THE PARIETAL HEMATOMA. BOTH HEMATOMA CAVITIES WERE TAMPONADED WITH HYDROGEN PEROXIDE-IMPREGNATED PLEDGETS AFTER BIOPSIES WERE TAKEN OF THE CAVITY WALLS. THE BIOPSY SPECIMENS DEMONSTRATED FRAGMENTS OF BRAIN TISSUE SHOWING PATCHY HEMORRHAGE AND FOCAL INFLAMMATION. BOTH FRESH AND RECENT BLOOD CLOT WAS INCLUDED IN THE SPECIMEN. NO NEOPLASM WAS IDENTIFIED FROM THE BIOPSY SPECIMENS. THE PLEDGETS WERE THEN REMOVED. THE NEUROSURGEON REPORTED OPERATIVE BLEEDING SUGGESTIVE OF SYSTEMIC ANTICOAGULATION DURING THE PROCEDURE EVEN THOUGH THE COAGULATION PROFILE WAS NORMAL DURING THE INITIAL EVALUATION OF THE PATIENT IN THE EMERGENCY DEPARTMENT. THE INCISION WAS CLOSED WITH A FLOATING BONE FLAP AND DURAL APPROXIMATION. NO CRANIECTOMY WAS PERFORMED. POST-OPERATIVELY, THE PATIENT CONTINUED WITH DECEREBRATE POSTURING AND NEVER GAINED CONSCIOUSNESS. ELECTROCEREBRAL SILENCE WAS ESTABLISHED THREE DAYS LATER, AND THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR ON A DIRECTIVE FROM HER CAREGIVER. THE PATIENT DIED THE NEXT DAY. THE SITE BECAME AWARE OF THE PATIENT'S CLINICAL DETERIORATION WHEN THE PATIENT DID NOT REPORT FOR THE SECOND SCHEDULED ECP TREATMENT ON ONE DAY AFTER THE ORIGINAL DATE. BECAUSE OF THE CIRCUMSTANCES OF THE CASE (SUSPICION OF FOUL PLAY, I.E., AN ASSAULT OUTSIDE OF A BANK), THE PATIENT WAS REFERRED TO THE COUNTY MEDICAL EXAMINER AND AN AUTOPSY WAS PERFORMED. ACCORDING TO THE CORONER'S REPORT, THE PRINCIPAL FINDINGS WERE: "1. HYPERTENSIVE AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE; MULTIFOCAL INTRACEREBRAL WHITE MATTER HEMORRHAGES; ARTERIOLONEPHROSCLEROSIS; BORDERLINE CARDIOMEGALY. ORGANIZING, THIN BILATERAL SUBDURAL HEMORRHAGES; HISTORY OF UNSPECIFIED MYELOPROLIFERATIVE DISORDER, STATUS POST BONE MARROW TRANSPLANT; CHRONIC GRAFT VERSUS HOST DISEASE; CHRONIC PHOTOPHERESIS, WITH FULL HEPARINIZATION PRIOR TO EACH TREATMENT; COAGULATION PARAMETERS WITHIN NORMAL LIMITS AT PRESENTATION TO HOSPITAL, CLINICAL. CHRONIC OBSTRUCTIVE PULMONARY DISEASE." THE OPINION OF THE CORONER WAS AS FOLLOWS: THE DECEDENT WAS FOUND ON THE GROUND BY HER MOTOR VEHICLE. SHE WAS TAKEN TO AN AREA HOSPITAL WHERE SHE WAS DIAGNOSED WITH AN INTRACRANIAL HEMORRHAGE AND DIED DESPITE AGGRESSIVE NEUROSURGICAL TREATMENT. AT EXAMINATION, MULTIPLE WHITE MATTER INTRACEREBRAL HEMORRHAGES WERE IDENTIFIED WITH ASSOCIATED EDEMA AND MIDLINE SHIFT. THIN, OLDER SUBDURAL HEMATOMA [SIC] WERE ALSO IDENTIFIED, INDICATING PREVIOUS ASYMPTOMATIC BLEEDING, POSSIBLY TRAUMATIC IN ORIGIN. THE RECENT, FATAL HEMORRHAGES, HOWEVER, WE WERE MOST LIKELY THE RESULT OF A HYPERTENSIVE CEREBRAL HEMORRHAGE (HEMORRHAGIC STROKE). OTHER FINDINGS ASSOCIATED WITH HYPERTENSIVE CARDIOVASCULAR DISEASE ARE ARTERIOLONEPHROSCLEROSIS. THIS FEMALE DIED AS A RESULT OF INTRACEREBRAL HEMORRHAGES DUE TO HYPERTENSIVE CARDIOVASCULAR DISEASE. THE PHOTOPHERESIS WITH HEPARIN ANTICOAGULATION, USED IN THE TREATMENT OF GRAFT VERSUS HOST DISEASE, IS A LIKELY CONTRIBUTOR TO THE DEATH. THE MANNER OF DEATH IS A COMPLICATION OF THERAPY." SPONSOR'S COMMENT: BECAUSE OF THE PROPENSITY OF HER CENTRAL VENOUS CATHETER TO CLOT DURING PHOTOPHERESIS PROCEDURES, THIS PATIENT RECEIVED TISSUE PLASMINOGEN ACTIVATOR (T-PA) DIRECTLY INTO THE CENTRAL VENOUS CATHETER IN ORDER TO PREVENT CATHETER THROMBOSIS. THE ADMINISTRATION OF T-PA OR ANY OTHER THROMBOLYTIC THERAPY IS NOT CONTAINED IN THE THERAKOS PHOTOPHERESIS OPERATOR'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UVAR XTS PHOTOPHERESIS KIT LNR THERAKOS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L