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 Abdominal Pain (1685); Fever (1858); Inflammation (1932); Liver Damage/Dysfunction (1954); Nausea (1970); Insufficient Information (4580)

Event Date 03/08/2021

Event Type  Injury  

Event Description

Reported via journal article that within this study, it was reported that patient postembolization syndrome, leucocytosis, and elevated liver function occurred.Clinical study results from turkey aim to compare resolution, size reducing effects, and complications of transcatheter arterial embolization (tae) and transcatheter arterial chemoembolization (tace) for the treatment of giant hepatic hemangiomas.A total of 104 patients underwent tace using bleomycin, and 108 patients underwent tae.The patients were followed-up for 2 year and follow-up images at 6 months, 12 months, and 24 months were acquired.Lesion volumes in both follow-up images were calculated.The patients were examined for any possible procedure related complications as well as the status of their initial symptoms.Embolization was performed by interventional radiologists with at least 5 years of experience.For tae, polyvinyl alcohol (pva) particles (355-500 contour were used as embolizing agent.In the treatment of tae, 2 vial pva was used in 86 of 128 hemangiomas in 108 cases, 3 vials and 3 vials in 14 patients.Second session embolization was required for 20 patients.All second session applications were performed in cases where it was seen that sufficient reduction and clinical benefit could not be achieved at the 12th month.After embolization, all patients were hospitalized for 24 hours.Their body temperature, blood pressure, and heart rate were monitored at 4 h intervals.Their complete blood count (cbc) was evaluated twice at 12 hour intervals, and liver function tests (lft) were evaluated after 24 hours.By the results of post embolization syndrome, post procedure abdominal pain was evaluated using the numeric pain rating scale, with values going from 0 to 10 as the pain increases (mccaffery pain scale).In cases who had pain that required analgesics, in addition to the routine follow-up measures described above, their cbcs were checked, and they also underwent abdominal ultrasonography to exclude hemorrhage.In the tae group (n = 108), 16 patients (14.8%) had 2 lesions and 2 patient (1.9%) had 3 lesions; rest of the patients had one lesion for a total of 128 hemangiomas.Mean lesion volume prior to treatment (considering total volume of all lesions in patients with multiple hemangiomas) was 294.48 plus or minus 22.81 cm3 (minimum 55.00, maximum 3280.00) for tae patients and 260.23 plus or minus 30.52 cm3 (minimum 37.00, maximum 3400.00) for tace patients.The values were similar for both groups (p = 0.526).Following either tace or tae, follow-up images at 6 months demonstrated that the mean lesion volume was 183.48 plus or minus 21.37 cm3 (minimum 25.00, maximum 1910.00) in tace group and 273.50 plus or minus 22.36 cm3 (minimum 45.00, maximum 2204.00) in tae group.In follow-up images at 12 months, mean lesion volume was 211.24 plus or minus 17.23 cm3 (minimum 40.00, maximum 775.00) in tae group and 53.38 plus or minus 6.16 cm3 (minimum 5.00, maximum 590.00) in tace group.In the 24th month follow-up, mean lesion volume was 52.13 plus or minus 5.94 cm3 (minimum 5.00, maximum 580.00) in tace group and 208.48 plus or minus 17.06 cm3 (minimum 40.00, maximum 770.00) in tae group.The shrinkage period was determined to have ended after 12 month in both groups.The results of the two-way mixed anova showed that there was significant main effect of procedure type (p less than or equal to 0.001) on hemangioma volumes.Similarly, there was a significant interaction between procedure and time (p less than or equal to 0.001).Following tae, all patients had postembolization syndrome consisting of abdominal pain, nausea, loss of appetite, and low-grade fever.The most common symptom was pain.According to mccaffery pain scale, the average score was 7.0 plus or minus 0.8 (95% ci 6.7 - 7.2, minimum 4, maximum 9, median 7).The patients were managed with mild analgesics.In 86 patients, the pain regressed in 24 hours; however, 22 patients (20.4%) had persistent pain because of which their hospitalization was extended to 48 hours.Following 48 hours, they, too, were discharged upon resolution of their pain.38 patients (35.2%) had low grade fever (<38.0 degrees c) not requiring medication.Three patients (5.6%) had temporary leucocytosis in the first week.Liver function tests were elevated in 48 patients (44.4%) and returned to less than twice the normal values or to normal limits in all but 12.The 12 patients where lfts remained elevated after 24 hours were followed-up for another 24 hours, and their lfts were within normal limits at the end of 48 hours.Postembolization pain, as graded according to the numeric pain scale, was less in the tace group than the patients who underwent tae (p < 0.001).The incidence of fever and lft elevation were similar in the two groups (p = 0.358 and p = 0.060, respectively).Mean duration of postprocedural hospitalization was shorter in the tace group (p = 0.27) and 48 hours of hospitalization was more common in tae group (p = 0.27).There was no life-threatening complications or longterm problems (except for the patient with decreased renal function) caused by the procedures.

Manufacturer Narrative

Date of event: used accepted/published online date.(b)(6).Ozhan ozgur, hakki timur sindel, department of radiology, giant hepatic hemangioma treatment with transcatheter arterial embolization and transcatheter arterial chemoembolization; comparative results, faculty of medicine, turkish journal of medical sciences: vol.51: no.6, article 17, (2021): 2943-2950.

Manufacturer Narrative

H6: patient codes: add code inflammation.H6: patient codes: remove code insufficient information.B3: date of event: used accepted/published online date.E1: initial reporter facility name: department of radiology, faculty of medicine, akdeniz university ozhan ozgur, hakki timur sindel, department of radiology, giant hepatic hemangioma treatment with transcatheter arterial embolization and transcatheter arterial chemoembolization; comparative results, faculty of medicine, turkish journal of medical sciences: vol.51: no.6, article 17, (2021): 2943-2950.

Event Description

Reported via journal article that within this study, it was reported that patient postembolization syndrome, leucocytosis, and elevated liver function occurred.Clinical study results from turkey aim to compare resolution, size reducing effects, and complications of transcatheter arterial embolization (tae) and transcatheter arterial chemoembolization (tace) for the treatment of giant hepatic hemangiomas.A total of 104 patients underwent tace using bleomycin, and 108 patients underwent tae.The patients were followed-up for 2 year and follow-up images at 6 months, 12 months, and 24 months were acquired.Lesion volumes in both follow-up images were calculated.The patients were examined for any possible procedure related complications as well as the status of their initial symptoms.Embolization was performed by interventional radiologists with at least 5 years of experience.For tae, polyvinyl alcohol (pva) particles (355-500 contour were used as embolizing agent.In the treatment of tae, 2 vial pva was used in 86 of 128 hemangiomas in 108 cases, 3 vials and 3 vials in 14 patients.Second session embolization was required for 20 patients.All second session applications were performed in cases where it was seen that sufficient reduction and clinical benefit could not be achieved at the 12th month.After embolization, all patients were hospitalized for 24 hours.Their body temperature, blood pressure, and heart rate were monitored at 4 h intervals.Their complete blood count (cbc) was evaluated twice at 12 hour intervals, and liver function tests (lft) were evaluated after 24 hours.By the results of post embolization syndrome, post procedure abdominal pain was evaluated using the numeric pain rating scale, with values going from 0 to 10 as the pain increases (mccaffery pain scale).In cases who had pain that required analgesics, in addition to the routine follow-up measures described above, their cbcs were checked, and they also underwent abdominal ultrasonography to exclude hemorrhage.In the tae group (n = 108), 16 patients (14.8%) had 2 lesions and 2 patient (1.9%) had 3 lesions; rest of the patients had one lesion for a total of 128 hemangiomas.Mean lesion volume prior to treatment (considering total volume of all lesions in patients with multiple hemangiomas) was 294.48 plus or minus 22.81 cm3 (minimum 55.00, maximum 3280.00) for tae patients and 260.23 plus or minus 30.52 cm3 (minimum 37.00, maximum 3400.00) for tace patients.The values were similar for both groups (p = 0.526).Following either tace or tae, follow-up images at 6 months demonstrated that the mean lesion volume was 183.48 plus or minus 21.37 cm3 (minimum 25.00, maximum 1910.00) in tace group and 273.50 plus or minus 22.36 cm3 (minimum 45.00, maximum 2204.00) in tae group.In follow-up images at 12 months, mean lesion volume was 211.24 plus or minus 17.23 cm3 (minimum 40.00, maximum 775.00) in tae group and 53.38 plus or minus 6.16 cm3 (minimum 5.00, maximum 590.00) in tace group.In the 24th month follow-up, mean lesion volume was 52.13 plus or minus 5.94 cm3 (minimum 5.00, maximum 580.00) in tace group and 208.48 plus or minus 17.06 cm3 (minimum 40.00, maximum 770.00) in tae group.The shrinkage period was determined to have ended after 12 month in both groups.The results of the two-way mixed anova showed that there was significant main effect of procedure type (p less than or equal to 0.001) on hemangioma volumes.Similarly, there was a significant interaction between procedure and time (p less than or equal to 0.001).Following tae, all patients had postembolization syndrome consisting of abdominal pain, nausea, loss of appetite, and low-grade fever.The most common symptom was pain.According to mccaffery pain scale, the average score was 7.0 plus or minus 0.8 (95% ci 6.7 - 7.2, minimum 4, maximum 9, median 7).The patients were managed with mild analgesics.In 86 patients, the pain regressed in 24 hours; however, 22 patients (20.4%) had persistent pain because of which their hospitalization was extended to 48 hours.Following 48 hours, they, too, were discharged upon resolution of their pain.38 patients (35.2%) had low grade fever (<38.0 degrees c) not requiring medication.Three patients (5.6%) had temporary leucocytosis in the first week.Liver function tests were elevated in 48 patients (44.4%) and returned to less than twice the normal values or to normal limits in all but 12.The 12 patients where lfts remained elevated after 24 hours were followed-up for another 24 hours, and their lfts were within normal limits at the end of 48 hours.Postembolization pain, as graded according to the numeric pain scale, was less in the tace group than the patients who underwent tae (p < 0.001).The incidence of fever and lft elevation were similar in the two groups (p = 0.358 and p = 0.060, respectively).Mean duration of postprocedural hospitalization was shorter in the tace group (p = 0.27) and 48 hours of hospitalization was more common in tae group (p = 0.27).There was no life-threatening complications or longterm problems (except for the patient with decreased renal function) caused by the procedures.

• 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 LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14949186
• MDR Text Key: 295451661
• Report Number: 2134265-2022-07652
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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: 07/25/2022
• 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): Required Intervention; Hospitalization