BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 10092189 · Received May 27, 2020

    Report

    Report Number
    1722028-2020-00251
    Event Type
    Death
    Date Received
    May 27, 2020
    Date of Event
    December 31, 2019
    Report Date
    May 27, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN E.1, H.6 AND H.10. INVESTIGATION: BASED ON THE CLINICAL AND INVESTIGATION FINDINGS, THE SPECTRA OPTIA DEVICE PERFORMED AS INTENDED, THERE WERE NO SUGGESTED DEVICE FAILURES, MALFUNCTIONS, MISLABELING, IMPROPER OR INADEQUATE DESIGN OR MANUFACTURING ERRORS, NOR WAS THERE ANY REPORTED USER ERRORS THAT CONTRIBUTED TO OR CAUSED THESE ADVERSE EVENT. PER THE ARTICLE, " RESULTS: BEFORE TPE, ALL PATIENTS HAD SEVERE HYPERTHYROIDISM, AND ANTITHYROID DRUGS WERE EITHER CONTRAINDICATED OR NOT SUFFICIENTLY EFFECTIVE TO RESTORE EUTHYROIDISM PROMPTLY. AFTER ALL THE TPES, FREE T4 (FT4) DECREASED SIGNIFICANTLY BY 48% (P = 0.001) AND FT3 BY 52% (P = 0.0001). THE MEDIAN NUMBER OF TPE SESSIONS PER PATIENT WAS 4 (RANGE: 1¿10). THE FIRST HORMONAL MEASUREMENT WAS PERFORMED BETWEEN 1 AND 10 H AFTER THE TPE SESSION, AND IT SHOWED A 20% DECREASE IN FT4 AND FT3 FROM THE PRE-TPE LEVEL. FT4 AND FT3 LEVELS WERE MEASURED, ON AVERAGE, 2 DAYS (RANGE 0¿11 DAYS) AFTER ALL TPE SESSIONS. FT4 DECREASED SIGNIFICANTLY BY 48% (P = 0.001) AND FT3 BY 52% (P = 0.001) (FIG. 1). TPE FAILED TO DECREASE THYROID HORMONE LEVELS IN 1 CASE (PATIENT NO. 8) DESPITE 3 SESSIONS." THE GOAL OF THE STUDY WAS TO EVALUATE THE USE OF THERAPEUTIC PLASMA EXCHANGE (TPE) IN HYPERTHYROID PATIENTS AND THEIR OUTCOME AFTER TPE. METHOD: THE AUTHORS RETROSPECTIVELY REVIEWED 22 PATIENTS WHO UNDERWENT TPE FOR REFRACTORY THYROTOXICOSIS IN THEIR INSTITUTION: 13 WITH GRAVES¿ DISEASE (GD), 7 WITH AMIODARONE-INDUCED THYROTOXICOSIS (AIT), 1 WITH TOXIC GOITER, AND 1 PREGNANT PATIENT WITH FAMILIAL NONAUTOIMMUNE THYROTOXICOSIS. RESULTS: BEFORE TPE, ALL PATIENTS HAD SEVERE HYPERTHYROIDISM, AND ANTITHYROID DRUGS WERE EITHER CONTRAINDICATED OR NOT SUFFICIENTLY EFFECTIVE TO RESTORE EUTHYROIDISM PROMPTLY. AFTER ALL THE TPES, FREE T4 (FT4) DECREASED SIGNIFICANTLY BY 48% (P = 0.001) AND FT3 BY 52% (P = 0.0001). THE MEDIAN NUMBER OF TPE SESSIONS PER PATIENT WAS 4 (RANGE: 1¿10). THE FIRST HORMONAL MEASUREMENT WAS PERFORMED BETWEEN 1 AND 10 H AFTER THE TPE SESSION, AND IT SHOWED A 20% DECREASE IN FT4 AND FT3 FROM THE PRE-TPE LEVEL. FT4 AND FT3 LEVELS WERE MEASURED, ON AVERAGE, 2 DAYS (RANGE 0¿11 DAYS) AFTER ALL TPE SESSIONS. FT4 DECREASED SIGNIFICANTLY BY 48% (P = 0.001) AND FT3 BY 52% (P = 0.001) (FIG. 1). TPE FAILED TO DECREASE THYROID HORMONE LEVELS IN 1 CASE (PATIENT NO. 8) DESPITE 3 SESSIONS. TPE RESTORED FT3 TO NORMAL LEVELS IN 2 PATIENTS (9%) IN AN AVERAGE TIME OF 3 DAYS. FT4 LEVELS WERE STRICTLY NORMALIZED IN 8 PATIENTS (36%) WITHIN AN AVERAGE OF 6 DAYS (RANGE 1¿19 DAYS). THE NORMALIZATION OF BOTH FT3 AND FT4 WAS ACHIEVED IN 1 PATIENT. NO COMPLICATIONS, E.G., HYPOTENSION AND CATHETERRELATED COMPLICATIONS (HEMATOMA, INFECTION, OR THROMBOSIS) WERE NOTED EITHER DURING OR AFTER THE TPE SESSIONS. AT THE END OF THE ITERATIVE TPE SESSIONS, NO HYPOCALCEMIA WAS OBSERVED. THE MEDIAN DECREASE IN HEMOGLOBIN WAS 1 G/DL; 4 PATIENTS SHOWED A SIGNIFICANT DECREASE (> 3 G/DL) BUT NONE OF THEM REQUIRED A TRANSFUSION. TPE WAS FOUND TO BE A GOOD PREPARATION FOR SURGERY IN OUR STUDY, AS THERE WERE NO SURGICAL OR ANESTHETIC COMPLICATIONS RECORDED EVEN IN PATIENTS WITH A HISTORY OF HEART DISEASE. IN A PREVIOUS STUDY, THE REPORTED SURGICAL MORBIDITY RATE WAS 29% IN PATIENTS OPERATED ON FOR AIT WITHOUT ANY TPE PREPARATION [8]. IN OUR STUDY, HYPOCALCEMIA WAS RECORDED IN 3 PATIENTS (19%) AFTER THYROIDECTOMY, WHICH CORRESPONDS TO THE REPORTED INCIDENCE OF TRANSITORY POSTOPERATIVE HYPOCALCEMIA IN THE LITERATURE [9, 10]. OZBEY ET AL. [11] RAISED THE AWARENESS OF THE DECREASE IN ANTITHROMBOTIC FACTORS AND THUS THE RISK OF PERIOPERATIVE BLEEDING IN THYROID SURGERY AFTER TPE. IN 3 THYROIDECTOMIES AFTER TPE FOR GD, SURGEONS RECORDED PERIOPERATIVE BLEEDING, BUT THERE WERE NO TRANSFUSIONS OR ADVERSE ANESTHETIC EVENTS. THERE WERE NO COMPLICATIONS DURING THE 91 TPE SESSIONS. TOTAL THYROIDECTOMY WITH NO SEVERE SIDE EFFECTS WAS PERFORMED ON 16/22 PATIENTS AND 1 OTHER PATIENT WAS TREATED WITH RADIOACTIVE IODINE. ONE PATIENT DIED FROM SEVERE THYROTOXICOSIS DURING MEDICAL CARE. THE REMAINING 4 PATIENTS WERE FOLLOWED UP WITHOUT ANY RADICAL TREATMENT. FOR ALL 7 PATIENTS WITH AIT, ITERATIVE TPE LED TO A SIGNIFICANT CLINICAL IMPROVEMENT, AND AMIODARONE WAS CONTINUED FOR 1 PATIENT. AVAILABLE TREATMENTS WERE CONTINUED BETWEEN TPE SESSIONS (CHOLESTYRAMINE FOR 13 PATIENTS [60%] AND GLUCOCORTICOIDS FOR 16 PATIENTS [73%]). CONCLUSION: TPE ALLOWED A SAFE DECREASE OF 50% IN THYROID HORMONE LEVELS, AND IT SHOULD BE CONSIDERED FOR REFRACTORY HYPERTHYROID PATIENTS WHEN MEDICAL TREATMENTS ARE CONTRAINDICATED OR HAVE FAILED TO RESTORE EUTHYROIDISM, IRRESPECTIVE OF THE ETIOLOGY OF THE THYROTOXICOSIS. ROOT CAUSE: THE PATIENT DEATH IS BELIEVED TO BE RELATED TO THE PATIENT'S PRE-EXISTING DISEASE STATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5 AND H.10. INVESTIGATION: SEVERE HYPERTHYROIDISM DUE TO AIT COMBINED WITH HEART FAILURE LED TO THE DEATH OF A 55-YEAR OLD WOMAN WITH DILATED CARDIOMYOPATHY WHO WAS AWAITING HEART TRANSPLANTATION, DESPITE THERAPEUTIC MANAGEMENT INCLUDING CORTICOSTEROIDS, CHOLESTYRAMINE, PROPYLTHIOURACIL (PTU), AND 3 TPE SESSIONS. THERE IS NO EVIDENCE TO INDICATE THAT THE SPECTRA OPTIA DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. THEREFORE, THERE IS NO FAILURE MODE OR ASSOCIATED RISK THAT CAN BE EVALUATED FOR SPECTRA OPTIA. DHR DETAILS: SINCE THIS WAS A RETROSPECTIVE CLINICAL STUDY TO EVALUATE THE USE OF THERAPEUTIC PLASMA EXCHANGE (TPE) IN HYPERTHYROID PATIENTS BETWEEN 2007 AND 2017, THE LOT NUMBERS ARE UNKNOWN; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THE REPORTED INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THIS WAS A RETROSPECTIVE CLINICAL STUDY TO EVALUATE THE USE OF THERAPEUTIC PLASMA EXCHANGE (TPE) IN HYPERTHYROID PATIENTS BETWEEN 2007 AND 2017, INVOLVING TWENTY-TWO PATIENTS. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: THE MEDIAN NUMBER OF TPE SESSIONS PER PATIENT WAS 4. THERE WERE NO COMPLICATIONS DURING THE 91 TPE SESSIONS. ARTICLE CITATION: SAIE, C., ET.AL. 2020. THERAPEUTIC PLASMA EXCHANGE IN REFRACTORY HYPERTHYROIDISM. EUROPEAN THYROID JOURNAL. DOI: 10.1159/000507019. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE ARTICLE, 'THERAPEUTIC PLASMA EXCHANGE IN REFRACTORY HYPERTHYROIDISM' (SAIE 2020) DESCRIBES A STUDY ON THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURES PERFORMED ON HYPERTHYROID PATIENTS. IT DESCRIBES A SERIES OF 22 PATIENTS WITH HYPERTHYROIDISM WHO UNDERWENT 91 TPE PROCEDURES BETWEEN 2007 AND THE FIRST SEMESTER OF 2017. ALL TPE PROCEDURES WERE PERFORMED WITH SPECTRA OPTIA. ONE PATIENT DEATH WAS REPORTED. PER THE ARTICLE, SEVERE HYPERTHYROIDISM DUE TO AMIODARONE-INDUCED THYROTOXICOSIS COMBINED WITH HEART FAILURE LED TO THE DEATH OF A (B)(6)-YEAR OLD WOMAN WITH DILATED CARDIOMYOPATHY WHO WAS AWAITING HEART TRANSPLANTATION, DESPITE THERAPEUTIC MANAGEMENT INCLUDING CORTICOSTEROIDS, CHOLESTYRAMINE, PTU, AND 3 TPE SESSIONS. DRUGS ADMINISTERED DURING TPE: CORTICOSTEROIDS (60 MG), CHOLESTYRAMINE (120 MG), PTU (300 MG) PATIENT WEIGHT IS NOT AVAILABLE AT THIS TIME. 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. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555883 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Female Other