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 Fever (1858); Necrosis (1971); Pain (1994); Vomiting (2144)

Event Date 01/25/2008

Event Type  Injury  

Event Description

It was reported via a journal article "uterine artery embolization in 101 cases of uterine fibroids: do size, location, and number of fibroids affect therapeutic success and complications?" that vomiting, pain, fever, and fibroid expulsion occurred following embolization.Abstract the purpose of this study was to evaluate whether the size, location, or number of fibroids affects therapeutic efficacy or complications of uterine artery embolization (uae).Patients with symptomatic uterine fibroids (n = 101) were treated by selective bilateral uae using 500 to 710 lm polyvinyl alcohol (pva) particles.Baseline measures of clinical symptoms, sonography, and mri taken before the procedure were compared to those taken 1, 3, 6, and 12 months later.Complications and outcomes were analyzed for associations with fibroid size, location, and number.Reductions in mean fibroid volume were similar in patients with single (66.6 +/- 21.5%) and multiple (67.4 +/- 25.0%) fibroids (p-value = 0.83).Menstrual improvement occurred in patients with single (93.3%) and multiple (72.2%) fibroids (p = 0.18).Changes in submucosal and other fibroids were not significantly different between the two groups (ps [0.56).Linear regression analysis between primary fibroid volume as independent variable and percentage reduction of fibroid volume after 1 year yielded an r2 of 0.083 and the model coefficient was not statistically significant (p = 0.072).Multivariate regression models revealed no statistically or clinically significant coefficients or odds ratios for three independent variables (primary fibroid size, total number, and fibroid location) and all outcome variables (percent reduction of uterus and fibroid volumes in 1 year, improvement of clinical symptoms [menstrual, bulk related, and urinary] in 1 year, and complications after uae).In conclusion, neither the success rate nor the probability of complications was affected by the primary fibroid size, location, or total number of fibroids.

Manufacturer Narrative

(b)(6).Firouznia, kavous, et al."uterine artery embolization in 101 cases of uterine fibroids: do size, location, and number of fibroids affect therapeutic success and complications?." cardiovascular and interventional radiology 31.3 (2008): 521-526.

• 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: 15125995
• MDR Text Key: 296845495
• Report Number: 2134265-2022-07946
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 06/30/2022
• 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