MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144); Weight Changes (2607); Unspecified Heart Problem (4454); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/16/2007

Event Type  Injury  

Manufacturer Narrative

(b)(6).Ruutiainen, alexander t., et al."chemoembolization and bland embolization of neuroendocrine tumor metastases to the liver." journal of vascular and interventional radiology 18.7 (2007): 847-855.

Event Description

It was reported via a journal article that patient complications occurred.Purpose: to assess the toxicity and efficacy of chemoembolization and bland embolization in patients with neuroendocrine tumor metastases to the liver.Materials and methods: a total of 67 patients underwent 219 embolization procedures: 23 patients received primarily bland embolization with pva with or without iodized oil and 44 primarily received chemoembolization with cisplatin, doxorubicin, mitomycin-c, iodized oil, and polyvinyl alcohol.Clinical, laboratory, and imaging follow-up was performed 1 month after completion of therapy and every 3 months thereafter.Patients with disease relapse were treated again when feasible.Toxicity was assessed according to national cancer institute common toxicity criteria for adverse events, version 3.0.Efficacy was assessed by clinical and morphologic response.Time to progression (ttp), time to treatment failure, and survival were estimated by kaplan - meier analysis.Results: ten of 67 patients (15%) were lost to follow-up.The mortality rate at 30 days was 1.4%.Toxicities of grade 3 or worse in severity occurred after 25% of chemoembolization procedures and 22% of bland embolization procedures (odds ratio, 1.2; 95% ci, 0.4 - 4.0).Mean length of stay was 1.5 day in both groups.Rates of freedom from progression at 1, 2, and 3 years were 49%, 49%, and 35% after chemoembolization and 0%, 0%, and 0% after bland embolization (log-rank test, p.16).Among the subgroup with carcinoid tumors, the proportions without progression were 65%, 65%, and 52% after chemoembolization and 0%, 0%, and 0% after bland embolization (log-rank test, p.08).Patients treated with chemoembolization and bland embolization experienced symptomatic relief for means of 15 and 7.5 months, respectively (p.14).Survival rates at 1, 3, and 5 years after therapy were 86%, 67%, and 50%, respectively, after chemoembolization and 68%, 46%, and 33%, respectively, after bland embolization (log-rank test, p.18).Conclusions: chemoembolization was not associated with a higher degree of toxicity than bland embolization.Chemoembolization demonstrated trends toward improvement in ttp, symptom control, and survival.Based on these results, a multicenter prospective randomized trial is warranted.

Manufacturer Narrative

H6 patient codes: corrected to unspecified heart problem e0623 and appropriate term/code not available e2402.The appropriate term/code not available e2402 was added for the report of post embolization syndrome.H6 impact codes: updated with minor injury/illness/impairment f11.E1 - initial reporter facility name: (b)(6) medical center.Ruutiainen, alexander t., et al."chemoembolization and bland embolization of neuroendocrine tumor metastases to the liver." journal of vascular and interventional radiology 18.7 (2007): 847-855.

Event Description

It was reported via a journal article that patient complications occurred.Purpose: to assess the toxicity and efficacy of chemoembolization and bland embolization in patients with neuroendocrine tumor metastases to the liver.Materials and methods: a total of 67 patients underwent 219 embolization procedures: 23 patients received primarily bland embolization with pva with or without iodized oil and 44 primarily received chemoembolization with cisplatin, doxorubicin, mitomycin-c, iodized oil, and polyvinyl alcohol.Clinical, laboratory, and imaging follow-up was performed 1 month after completion of therapy and every 3 months thereafter.Patients with disease relapse were treated again when feasible.Toxicity was assessed according to national cancer institute common toxicity criteria for adverse events, version 3.0.Efficacy was assessed by clinical and morphologic response.Time to progression (ttp), time to treatment failure, and survival were estimated by kaplan - meier analysis.Results: ten of 67 patients (15%) were lost to follow-up.The mortality rate at 30 days was 1.4%.Toxicities of grade 3 or worse in severity occurred after 25% of chemoembolization procedures and 22% of bland embolization procedures (odds ratio, 1.2; 95% ci, 0.4 - 4.0).Mean length of stay was 1.5 day in both groups.Rates of freedom from progression at 1, 2, and 3 years were 49%, 49%, and 35% after chemoembolization and 0%, 0%, and 0% after bland embolization (log-rank test, p.16).Among the subgroup with carcinoid tumors, the proportions without progression were 65%, 65%, and 52% after chemoembolization and 0%, 0%, and 0% after bland embolization (log-rank test, p.08).Patients treated with chemoembolization and bland embolization experienced symptomatic relief for means of 15 and 7.5 months, respectively (p.14).Survival rates at 1, 3, and 5 years after therapy were 86%, 67%, and 50%, respectively, after chemoembolization and 68%, 46%, and 33%, respectively, after bland embolization (log-rank test, p.18).Toxicities were graded according to ctcae version 3.0 criteria (18) for each embolization procedure for pain, fever, nausea, vomiting, fatigue, weight loss, increases in serum aminotransferase and alkaline phosphatase levels, infection, cardiac complications, and any other recorded toxicities.Although the incidence of some degree of postembolization syndrome was quite high, these symptoms were generally well controlled and self-limited.Severe toxicities (ctcae grade 3) occurred in 11 of 44 chemoembolization procedures (25%) and five of 23 bland embolization procedures (22%; odds ratio, 1.2; 95% ci, 0.4 to 4.0).The only significant difference among toxicities of any grade was an increased incidence of infections among patients in the chemoembolization group (p 0.01).This may be related to the greater prevalence of a bilioenteric anastomosis or stent in the chemoembolization group, although the numbers are too small for statistical comparison.Nevertheless, infection was rare (6%), mild, and self-limited; only 1% of the patients experienced an infection of grade 3 or greater.Conclusions: chemoembolization was not associated with a higher degree of toxicity than bland embolization.Chemoembolization demonstrated trends toward improvement in ttp, symptom control, and survival.Based on these results, a multicenter prospective randomized trial is warranted.

• Brand Name: CONTOUR
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15068328
• MDR Text Key: 296261472
• Report Number: 2134265-2022-07935
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other