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); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Insufficient Information (4580)

Event Date 01/10/2015

Event Type  Injury  

Event Description

It was reported via a journal article that patient complications occurred.Between 28 april 2008 and 31 december 2012, 303 uae were performed in our department.The mean age of the patients was 42.3 years (range 24 - 54 years).Leading symptoms were strong menstrual bleeding accompanied by pelvic pain, anemia, and urgent sensation of urination.Some of our patients reported fertility problems or subsequent desire for pregnancy.All treated patients had full documentation of symptoms (table 1), previous gynecological history, diameters of the largest fibroid, and follow up information including complications.Before embolization, imaging of the uterus was typically done by pelvic ce-mr.For 7 out of 303 patients, mr was not done predominantly due to claustrophobia, for these patients, transabdominal or transvaginal ultrasound was performed.Clinical efficacy was assessed using numerical analog quality-of-life score (0-unbearable symptoms; 100-perfect quality of life) before and after the procedure.All periprocedural and postprocedural complications were listed during the procedure and at the follow up interviews.Minor complications included temporary fever (not longer than 4 weeks without any need of antibiotics), temporary amenorrhea, long-lasting postprocedural menstrual bleeding, postprocedural dysmenorrhea, aspecific infection (fever without pelvic complication and need for antibiotics).These complications did not require hospitalization or remarkable medication.Major complications were determined as myoma expulsion, emergency myomectomy, or emergency hysterectomy due to infectious complication of the necrotized fibroid.Elective myomectomy or elective hysterectomy was also listed.The patients were divided into two groups based on the largest diameter of the largest fibroid; group 1: diameter b10 cm, and group 2: diameter [10 cm.Statistical analysis of the relationship between fibroid diameter and complications was performed using fishers exact test.Mann - whitney u test was applied for the statistical analysis of quality-of-life score in the two groups.Uae was performed using a standard technique with right common femoral arterial punctures and bilateral catheterization of the uterine arteries with 4f catheters.In 19 cases (all belonged to group 1), only unilateral embolization was done because of tortuous origin of the uterine artery, early venous filling, retrograde filling of the ovarian artery, or unidentifiable uterine artery.Embolization was performed using nonspherical polyvinyl alcohol (pva) particles 500 - 700 and 355 - 500 lm in diameter (contour; boston scientific-target therapeutic (b)(4)).The angiographic end point for embolization was defined as near stasis of contrast medium flow in the uterine arteries.Manual compression was applied to the puncture site at the end of the procedure.All embolization procedures were done by the same interventional radiologist with more than 15 years experience.All patients were given antibiotics (amoxicillin or clindamycin) immediately before the procedure and during the hospital stay.Pain was managed with intravenous nalbuphine (morphinan derivative), pyrazolone, and nonsteroid anti-inflammatory drugs.After uae, patients were kept in the hospital overnight for observation.Complications in group 1: the vast majority of these complications were minor, such as fever (12 cases), temporary amenorrhea (7), prolonged menstruation (4), aspecific infection (2), intermittent menorrhagia (4), aspecific infection (2), postprocedural dysmenorrhea (23), and intermittent menorrhagia (4).Among major complications, expulsion of a fibroid was reported in 4 cases, all of them appeared in between the 2 weeks and 3 month following uterine fibroid embolization (ufe); one of these patients needed supplementary surgical gynecological intervention to complete the expulsion.In 2 cases, acute hysterectomy was necessary on the 5th and 9th postprocedural week followed by appearance of strong pelvic pain, fever, and elevated septic blood parameters in both patients.Elective myomectomy was done because of persistent symptoms, 7.5 months following ufe (table 3).All 19 patients who had unilateral embolization belonged to group 1, follow-up is available in 12 cases and none of them had remarkable complications.Complications in group 2: the following minor complications were documented: fever (5 cases), temporary amenorrhea (1), aspecific infection (1), postprocedural dysmenorrhea (2), and intermittent menorrhagia (1).Major complications as fibroid expulsion of the fibroid were reported in 1 case, the necrotized fibroid tissue appeared in the cervical canal in the 6th post-interventional month.As septic complications, one emergency myomectomy occurred in the 6th postprocedural week; acute hysterectomy was reported in 2 cases, 3, and 6 weeks following uae (table 3).An elective myomectomy was reported 8 months after uae because the embolized fibroid grew back to the preembolization size resulting in symptom recurrence.In another case, the large uterine mass was unchanged in size and unusually strong post-interventional blood flow was detected during transvaginal ultrasound, malignancy was suspected.Hysterectomy was decided, elective surgery was performed 8 months after uae; subsequent histology.

Manufacturer Narrative

Initial reporter facility name: (b)(6).Berczi, viktor, et al."safety and effectiveness of ufe in fibroids larger than 10 cm." cardiovascular and interventional radiology 38.5 (2015): 1152-1156.

• 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: 14958324
• MDR Text Key: 295509455
• Report Number: 2134265-2022-07637
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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: 06/29/2022
• 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