MAUDE MDR 9860139

MDR report key
9860139
Report number
1722028-2020-00118
Event key
0
Event type
3
Date of event
2020-01-26
Date received
2020-03-20
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SCOT HILDEN
Address
10810 W. COLLINS AVE LAKEWOOD CO 80215 US
Phone
303-303-3032
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPECTRA OPTIASPECTRA OPTIA EXCHANGE SETTERUMO BCTLKN10220R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. O

Event Narratives#

N

Patient 1

LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: THIS WAS A RETROSPECTIVE STUDY IN A MULTI-INSTITUTIONAL COHORT OF 109 PATIENTS WITH ITTP BETWEEN 2004 AND 2017. THIS STUDY INCLUDED PATIENTS PRESENTING BETWEEN JANUARY 8, 2004, AND APRIL 26, 2017, WITH CONFIRMED ITTP AT FOUR LARGE ACADEMIC MEDICAL CENTERS IN BOSTON. VENOUS ACCESS WAS OFTEN OBTAINED VIA TEMPORARY DUAL-LUMEN APHERESIS CATHETERS PLACED IN THE INTERNAL JUGULAR OR, LESS COMMONLY, THE FEMORAL VEIN. PROCEDURES WERE PERFORMED USING AN APHERESIS MACHINE (COBE SPECTRA OR OPTIA, TERUMO BCT). BOTH STANDARD (NOT VIRUS INACTIVATED) FRESH FROZEN PLASMA AND CRYOPRECIPITATE-POOR PLASMA WERE USED AS REPLACEMENT FLUID, AS DESIGNATED BY THE TREATING PHYSICIAN. ANTICOAGULANT CITRATE DEXTROSE A SOLUTION WAS ROUTINELY INFUSED AT 1:10 INLET RATIO FOR ANTICOAGULATION. CALCIUM GLUCONATE WAS INFUSED CONTINUOUSLY THROUGHOUT EACH PROCEDURE, AND THE INFUSION RATE WAS INCREASED IN THE SETTING OF SYMPTOMATIC HYPOCALCEMIA. IONIZED CALCIUM WAS NOT ROUTINELY MEASURED WHEN SYMPTOMS OF HYPOCALCEMIA WERE REPORTED. MOST PATIENTS UNDERWENT DAILY, ONE PLASMA-VOLUME EXCHANGES. THEY IDENTIFIED 124 PATIENTS WHO PRESENTED WITH ACUTE ITTP BETWEEN JANUARY 8, 2004, AND APRIL 26, 2017, AT ONE OF THE SIX PARTICIPATING INSTITUTIONS. THE MAJORITY OF PATIENTS WERE TREATED AT HOSPITALS WITHIN THE HARVARD TMA RESEARCH COLLABORATIVE (TABLE 1). OVERALL, 104 PATIENTS WERE ENROLLED DURING THEIR FIRST EPISODE OF ACUTE ITTP, WHILE 20 WERE ENROLLED DURING A RELAPSED PRESENTATION. THE MEDIAN (INTERQUARTILE RANGE [IQR]) AGE OF OUR PATIENT COHORT WAS 42 YEARS (31-52), 69% WERE FEMALE, AND 42% WERE NON-CAUCASIAN. THE MEDIAN (IQR) PLATELET COUNT AT PRESENTATION WAS 16,000 (10,000-22,000) PER MICROLITER, AND THE MEDIAN (IQR) ADAMTS13 ACTIVITY LEVEL WAS 0% (0%-0%). THE VAST MAJORITY OF PATIENTS WERE TREATED DURING THE INDEX EVENT (DEFINED AS THE EVENT THAT LED TO THEIR ENROLLMENT IN OUR STUDY). THE AUTHORS HAD HYPOTHESIZED THAT REFRACTORY DISEASE, AS DEFINED BY A HIGH NUMBER OF TPE TREATMENTS OR LONG DURATION OF HOSPITALIZATION, MIGHT BE ASSOCIATED WITH MORTALITY IN THE STUDY. HOWEVER, THEY FOUND THAT NEITHER EXTREMES IN LENGTH OF HOSPITAL STAY NOR NUMBER OF TPE PROCEDURES WAS PREDICTIVE OF MORTALITY. THE MAJORITY OF DEATHS (5/8) WERE ASSOCIATED WITH DELAY IN THE DIAGNOSIS OF ITTP OR INITIATION OF TPE OR PRESENTATION TO THE HOSPITAL IN A MORIBUND STATE. ARTICLE CITATION: COLLING, M., ET. AL. 2020. DEATHS AND COMPLICATIONS ASSOCIATED WITH THE MANAGEMENT OF ACUTE IMMUNE THROMBOTIC THROMBOCYTOPENIC PURPURA. TRANSFUSION 2020;9999;1?6. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

PER THE ARTICLE 'DEATHS AND COMPLICATIONS ASSOCIATED WITH THE MANAGEMENT OF ACUTE IMMUNE THROMBOTIC THROMBOCYTOPENIC PURPURA' IN THE JOURNAL TRANSFUSION, A RETROSPECTIVE STUDY WAS PERFORMED ON 109 IMMUNE THROMBOTIC THROMBOCYTOPENIC PURPURA (ITTP) PATIENTS BETWEEN 2004 AND 2017. COMPLICATIONS OF THERAPEUTIC PLASMA EXCHANGE (TPE) WERE ANALYZED IN A SUBSET OF THE COHORT. FOUR DEATHS OCCURRED IN THE STUDY FOR PATIENTS WHO HAD UNDERGONE TPE PROCEDURES. THIS REPORT IS FOR ONE OF THE FOUR PATIENTS WHO EXPIRED. ALL DEATHS RECORDED IN THE COHORT WERE CONSIDERED. AN ITTP RELATED DEATH WAS DEFINED AS ANY DEATH OCCURRING WITHIN 90 DAYS OF THE ONSET OF ACTIVE DISEASE REGARDLESS OF CLINICAL RECOVERY AND HOSPITAL DISCHARGE. THIS PATIENT DIED AFTER ONE SESSION OF TPE. PER THE ARTICLE, THIS PATIENT WAS PRESUMED IDIOPATHIC THROMBOCYTOPENIA PURPURA (ITP), RECEIVED STEROIDS ALONE FOR 48 HOURS AND EXPERIENCED NEUROLOGICAL DECLINE. PATIENT WEIGHT IS UNAVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, THOUGH AT THIS TIME THERE IS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH.