MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOZENE MICROSPHERES; EMBOLIC DEVICE

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

Patient Problems Hemorrhage/Bleeding (1888); Prolapse (2475)

Event Date 01/04/2022

Event Type  Injury  

Event Description

It was reported via a journal article that patient complications occurred.The pure study is a randomised controlled trial (rct) comparing the clinical and mri outcomes of patients treated with non-spherical polyvinyl alcohol, ns-pva (contour pva - boston scientific-355-500 & 500-700 microns) versus calibrated hydrogel microspheres (embozene - varian inc 700 & 900 microns) for symptomatic uterine fibroids.Materials and methods: prospective, ethically approved non-sponsored rct in 84 patients in a single uk tertiary ir unit, isrctn registry trial number isrctn18191539 in 2013 and 2014.All patients with symptomatic fibroid disease were eligible.Uae followed standardised protocol with ufs-qol and contrast-enhanced mri before and 6 months post uae.Outcome measures included: (1) uterine fibroid symptom and quality of life questionnaire (ufs-qol).(2) percentage total and dominant fibroid infarction.(3) uterine and dominant fibroid volume reduction.(4) volume of embolics.Results: sixty-three patients completed the qol follow-up (33 ns-pva vs 30 embozenes), the groups were equivalent at baseline.Patients were followed up for 6 months following uae.There was no significant difference in symptom scores or hr-qol between ns-pva and embozenes, p = 0.67 and 0.21, respectively.92.7% of patients treated with ns-pva achieved [90% dominant fibroid infarction versus 61.8% treated with embozenes (p = 0.0016).66% of patients treated with ns = pva achieved [90% total fibroid percentage infarction compared with 35% in the embozene group (p = 0.011).The mean vials/syringes used were 5.2 with embozenes versus 4.1 using pva (p = 0.08).One patient experienced a major adverse event which was felt to be unrelated to the trial itself but an unexpected complication of uterine artery embolisation for a submucosal fibroid.This was considered a grade three complication according to cirse classification to report adverse events [14].A 35-year-old patient underwent uae with embozenes for a solitary submucosal fibroid.Her initial recovery was uneventful but 10 days later she represented with vaginal bleeding, later requiring blood transfusion and mri revealed uterine prolapse, then proceeding to laparotomy to correct uterine inversion and at that time myomectomy of the solitary fibroid was performed.

Manufacturer Narrative

Date of event: article publication date used.Initial reporter facility name: (b)(6).Das, raj, et al."randomised controlled trial of particles used in uterine fibroid embolisation (pure): non-spherical polyvinyl alcohol versus calibrated microspheres." cardiovascular and interventional radiology 45.2 (2022): 207-215.

• Brand Name: EMBOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15176099
• MDR Text Key: 297347672
• Report Number: 2134265-2022-08383
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• 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: 07/12/2022
• 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