| Catalog Number |
12220 |
| Medical Device Problem Codes |
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Codes |
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
05/31/2024
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Type of Reportable Event
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Death
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Event or Problem Description
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Per journal article "outcomes of therapeutic plasma exchange for the treatment of patients with multiple myeloma cast nephropathy" by dima, d., goel, u., sannareddy, a., et al abstract: current treatment guidelines of myeloma cast nephropathy (mcn) recommend the institution of plasma cell-directed therapy and consideration of therapeutic plasma exchange (tpe), with the goal of rapid reduction of the serum free light chain (sflc).However, the role of tpe continues to remain a subject of debate.The goal of this retrospective bi-institutional study was to evaluate the clinical outcomes of tpe in combination with systemic therapy.Eighty patients were included in this analysis, of whom 72.5% had =50% drop in their initial involved sflc.At 3 months from tpe initiation, the overall hematologic response rate (orr) was 67.5% with a very good partial response or better (=vgpr) rate of 40%.At 6 months, orr was 57.5%, with =vgpr rate of 49%.The renal response rate at 3 and 6 months was 47.5% and 43.75%, respectively; the overall renal response rate was 48.75%.On multivariable analysis, every one unit increase in baseline creatinine (odds ratio "[or]" 0.76, p = 0.006), and achievement of =vgpr (or 21.7 p < 0.0001) were significantly associated with renal response.Also, a =50% drop in sflc was favorably associated with renal response (or 3.39, p = 0.09).With a median follow-up of 36.4 months, the median overall survival (os) was 11 months.On multivariable analysis, achievement of renal response (hazard ratio "[hr]" 0.3, p < 0.0001) and newly diagnosed disease (ndmm; hr 0.43, p = 0.0055) were associated with improved os.Among ndmm patients, those treated with daratumumab-based regimens had a trend for better os (p = 0.15), compared to other regimens, but the difference was not significant.At the end of follow-up, an estimated 40.4% of patients who were on dialysis were able to become dialysis independent.In conclusion, our study highlights the poor survival of patients with mcn.Achievement of early renal response is crucial for prolonged os, with daratumumab-based therapies showing promise.From the article: the renal response rate for all patients at 3 and 6 months was 47.5% and 43.75% respectively (table 2).Best overall renal response rate was 48.75% (figure 1a).Among the 38 patients who achieved renal response at 3 months, 4 patients died by 6 months.Of the 26 patients who did not achieve renal response by 3 months, 1 patient achieved a renal response at 6 months, 8 patients died, and 17 patients remained without renal response at 6 months.The collection set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.
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Additional Manufacturer Narrative
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Lot number, manufacture date and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: dima, d., goel, u., sannareddy, a., ibeh, n., ullah, f., afrough, a., mazzoni, s., mehdi, a., rudoni, j., raza, s., de simone, n., williams, l., khan, a., rashid, a., rice, m., ricci, k., samaras, c., valent, j., anderson, l.D.,.Khouri, j.(2024).Outcomes of therapeutic plasma exchange for the treatment of patients with multiple myeloma cast nephropathy.Hematological oncology, 42(4), e3293.Https://doi.Org/10.1002/hon.3293.
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Additional Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.11.Investigation: the goal of this retrospective study was to assess the patterns of utilization of tpe for mcn in two large academic u.S.Institutions, evaluate the clinical outcomes of tpe in conjunction with systemic anti-myeloma therapy, and determine factors associated with improved renal response and survival outcomes.Tpe was given concurrently with chemotherapy and was performed daily or every other day for the most part.One plasma volume was exchanged for all patients with al- bumin, normal saline with or without plasma.Anticoagulant citrate dextrose solution a was used for anticoagulation purposes.To mitigate the potential removal of daratumumab (dara) by the apheresis machine, dara was always given after tpe.A total of 80 patients were included, the median number of tpe sessions received was 4.Of all patients, 64 (81%) received tpe sessions daily, 1 patient received tpe every other day, and 14 (18%) received tpe variably (data not available for one patient).Regarding terumo bct product, spectra optia, a total of 58 (72.5%) patients had a =50% drop in their initial involved sflc.The median number of sessions required to achieve a =50% drop in the involved sflc among all patients was 3 sessions.At 3 months from tpe initiation, the overall hematologic response rate (orr) was 67.5% with a very good partial response or better (=vgpr) rate of 40%.At 6 months, orr was 57.5%, with a =vgpr rate of 49%.The renal response rate for all patients at 3 and 6 months was 47.5% and 43.75% respectively.Among the 38 patients who achieved renal response at 3 months, 4 patients died by 6 months.Of the 26 patients who did not achieve renal response by 3 months, 1 patient achieved a renal response at 6 months, 8 patients died, and 17 patients remained without renal response at 6 months.The authors did not disclose the time between finishing the tpe procedure and the patient death.It is unknown if the patient death occurred 72 hours or less following the therapeutic procedure.The authors concluded that their study highlights the poor survival of patients with mm cast nephropathy even with systemic anti-myeloma therapy in conjunction with tpe.Since this was a retrospective analysis of adult patients with myeloma-associated cast nephropathy between 1 january 2016 and 1 july 2023, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.Citation: dima, d., goel, u., sannareddy, a., ibeh, n., ullah, f., afrough, a., mazzoni, s., mehdi, a., rudoni, j., raza, s., de simone, n., williams, l., khan, a., rashid, a., rice, m., ricci, k., samaras, c., valent, j., anderson, l.D., khouri, j.(2024).Outcomes of therapeutic plasma exchange for the treatment of patients with multiple myeloma cast nephropathy.Hematological oncology, 42(4), e3293.Https://doi.Org/10.1002/hon.3293.
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Event or Problem Description
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Per journal article "outcomes of therapeutic plasma exchange for the treatment of patients with multiple myeloma cast nephropathy" by dima, d., goel, u., sannareddy, a., et al abstract: current treatment guidelines of myeloma cast nephropathy (mcn) recommend the institution of plasma cell-directed therapy and consideration of therapeutic plasma exchange (tpe), with the goal of rapid reduction of the serum free light chain (sflc).However, the role of tpe continues to remain a subject of debate.The goal of this retrospective bi-institutional study was to evaluate the clinical outcomes of tpe in combination with systemic therapy.Eighty patients were included in this analysis, of whom 72.5% had =50% drop in their initial involved sflc.At 3 months from tpe initiation, the overall hematologic response rate (orr) was 67.5% with a very good partial response or better (=vgpr) rate of 40%.At 6 months, orr was 57.5%, with =vgpr rate of 49%.The renal response rate at 3 and 6 months was 47.5% and 43.75%, respectively; the overall renal response rate was 48.75%.On multivariable analysis, every one unit increase in baseline creatinine (odds ratio "[or]" 0.76, p = 0.006), and achievement of =vgpr (or 21.7 p < 0.0001) were significantly associated with renal response.Also, a =50% drop in sflc was favorably associated with renal response (or 3.39, p = 0.09).With a median follow-up of 36.4 months, the median overall survival (os) was 11 months.On multivariable analysis, achievement of renal response (hazard ratio "[hr]" 0.3, p < 0.0001) and newly diagnosed disease (ndmm; hr 0.43, p = 0.0055) were associated with improved os.Among ndmm patients, those treated with daratumumab-based regimens had a trend for better os (p = 0.15), compared to other regimens, but the difference was not significant.At the end of follow-up, an estimated 40.4% of patients who were on dialysis were able to become dialysis independent.In conclusion, our study highlights the poor survival of patients with mcn.Achievement of early renal response is crucial for prolonged os, with daratumumab-based therapies showing promise.From the article: the renal response rate for all patients at 3 and 6 months was 47.5% and 43.75% respectively (table 2).Best overall renal response rate was 48.75% (figure 1a).Among the 38 patients who achieved renal response at 3 months, 4 patients died by 6 months.Of the 26 patients who did not achieve renal response by 3 months, 1 patient achieved a renal response at 6 months, 8 patients died, and 17 patients remained without renal response at 6 months.The collection set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.
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Event or Problem Description
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Per journal article "outcomes of therapeutic plasma exchange for the treatment of patients with multiple myeloma cast nephropathy" by dima, d., goel, u., sannareddy, a., et al abstract: current treatment guidelines of myeloma cast nephropathy (mcn) recommend the institution of plasma celldirected therapy and consideration of therapeutic plasma exchange (tpe), with the goal of rapid reduction of the serum free light chain (sflc).However, the role of tpe continues to remain a subject of debate.The goal of this retrospective biinstitutional study was to evaluate the clinical outcomes of tpe in combination with systemic therapy.Eighty patients were included in this analysis, of whom 72.5% had 50% drop in their initial involved sflc.At 3 months from tpe initiation, the overall hematologic response rate (orr) was 67.5% with a very good partial response or better (vgpr) rate of 40%.At 6 months, orr was 57.5%, with vgpr rate of 49%.The renal response rate at 3 and 6 months was 47.5% and 43.75%, respectively; the overall renal response rate was 48.75%.On multivariable analysis, every one unit increase in baseline creatinine (odds ratio "[or]" 0.76, p = 0.006), and achievement of vgpr (or 21.7 p 0.0001) were significantly associated with renal response.Also, a 50% drop in sflc was favorably associated with renal response (or 3.39, p = 0.09).With a median followup of 36.4 months, the median overall survival (os) was 11 months.On multivariable analysis, achievement of renal response (hazard ratio "[hr]" 0.3, p 0.0001) and newly diagnosed disease (ndmm; hr 0.43, p = 0.0055) were associated with improved os.Among ndmm patients, those treated with daratumumabbased regimens had a trend for better os (p = 0.15), compared to other regimens, but the difference was not significant.At the end of followup, an estimated 40.4% of patients who were on dialysis were able to become dialysis independent.In conclusion, our study highlights the poor survival of patients with mcn.Achievement of early renal response is crucial for prolonged os, with daratumumabbased therapies showing promise.From the article: the renal response rate for all patients at 3 and 6 months was 47.5% and 43.75% respectively (table 2).Best overall renal response rate was 48.75% (figure 1a).Among the 38 patients who achieved renal response at 3 months, 4 patients died by 6 months.Of the 26 patients who did not achieve renal response by 3 months, 1 patient achieved a renal response at 6 months, 8 patients died, and 17 patients remained without renal response at 6 months.The collection set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Specific details such as patient information and outcome were not included in the article for these events therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.
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Additional Manufacturer Narrative
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This report is being filed to provide additional information in g.1, h.6 and h.11.Investigation: the goal of this retrospective study was to assess the patterns of utilization of tpe for mcn in two large academic u.S.Institutions, evaluate the clinical outcomes of tpe in conjunction with systemic anti¿myeloma therapy, and determine factors associated with improved renal response and survival outcomes.Tpe was given concurrently with chemotherapy and was performed daily or every other day for the most part.One plasma volume was exchanged for all patients with al- bumin, normal saline with or without plasma.Anticoagulant citrate dextrose solution a was used for anticoagulation purposes.To mitigate the potential removal of daratumumab (dara) by the apheresis machine, dara was always given after tpe.A total of 80 patients were included, the median number of tpe sessions received was 4.Of all patients, 64 (81%) received tpe sessions daily, 1 patient received tpe every other day, and 14 (18%) received tpe variably (data not available for one patient). regarding terumo bct product, spectra optia, a total of 58 (72.5%) patients had a ¿50% drop in their initial involved sflc.The median number of sessions required to achieve a ¿50% drop in the involved sflc among all patients was 3 sessions.At 3 months from tpe initiation, the overall hematologic response rate (orr) was 67.5% with a very good partial response or better (¿vgpr) rate of 40%.At 6 months, orr was 57.5%, with a ¿vgpr rate of 49%.The renal response rate for all patients at 3 and 6 months was 47.5% and 43.75% respectively. among the 38 patients who achieved renal response at 3 months, 4 patients died by 6 months.Of the 26 patients who did not achieve renal response by 3 months, 1 patient achieved a renal response at 6 months, 8 patients died, and 17 patients remained without renal response at 6 months. the authors did not disclose the time between finishing the tpe procedure and the patient death.It is unknown if the patient death occurred 72 hours or less following the therapeutic procedure. the authors concluded that their study highlights the poor survival of patients with mm cast nephropathy even with systemic anti¿myeloma therapy in conjunction with tpe.Since this was a retrospective analysis of adult patients with myeloma¿associated cast nephropathy between 1 january 2016 and 1 july 2023, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Per terumo bct's medical review, the device did not cause or contribute to this incident.Root cause: a root cause assessment was performed for the patients' deaths.Based on the available information a definitive root cause could not be determined but it is likely that the patient died as a result of multiple myeloma cast nephropathy and/or comorbidities.Citation: dima, d., goel, u., sannareddy, a., ibeh, n., ullah, f., afrough, a., mazzoni, s., mehdi, a., rudoni, j., raza, s., de simone, n., williams, l., khan, a., rashid, a., rice, m., ricci, k., samaras, c., valent, j., anderson, l.D.,.Khouri, j.(2024).Outcomes of therapeutic plasma exchange for the treatment of patients with multiple myeloma cast nephropathy.Hematological oncology, 42(4), e3293.Https://doi.Org/10.1002/hon.3293.
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Search Alerts/Recalls
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