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); Hemorrhage/Bleeding (1888); Pain (1994); Constipation (3274); Decreased Appetite (4569); Swelling/ Edema (4577); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2008

Event Type  Injury  

Manufacturer Narrative

Pisco, joao m., et al."pelvic pain after uterine artery embolization: a prospective randomized study of polyvinyl alcohol particles mixed with ketoprofen versus bland polyvinyl alcohol particles." journal of vascular and interventional radiology 19.11 (2008): 1537-1542.

Event Description

It was reported via a journal article that patient complications occurred.Purpose: to evaluate whether pelvic pain following uterine artery embolization (uae) can be decreased by using ketoprofen mixed with polyvinyl alcohol (pva).Materials and methods: a randomized prospective study was performed in 80 patients (age range, 25 - 52 years; mean age, 41 years) undergoing uae with pva between march and august 2006.Forty patients received pva particles mixed with ketoprofen, and 40 received bland pva particles.Fifty-three patients who were asymptomatic 8 hours after embolization were discharged.Pain scores were compared during the first 8 hours after the procedure, at discharge, and the following day.The results were evaluated after 6 months.Results: eight hours after uae, 13 of the 40 patients in the group without ketoprofen (32%) reported severe or very severe pain, whereas none of the patients in the group receiving ketoprofen reported severe or very severe pain, as determined with a numeric pain score scale (p.0015).Nineteen of the 40 patients without ketoprofen (48%) were treated as inpatients, but only 10 in the ketoprofen group (25%) were treated as inpatients.The differences in the clinical outcome, as well in the uterus and fibroid sizes at discharge and at 6 months, were not statistically significant (p >.05).Conclusions: the use of pva particles mixed with ketoprofen resulted in a statistically significant reduction in pelvic pain during the first 8 hours after uae as compared to the use of pva alone.However, no significant differences in pain scores were seen after 8 hours.These findings may lead to a reduction in inpatient management for uae; however, further study of this approach is warranted.

Event Description

It was reported via a journal article that patient complications occurred.Purpose: to evaluate whether pelvic pain following uterine artery embolization (uae) can be decreased by using ketoprofen mixed with polyvinyl alcohol (pva).Materials and methods: a randomized prospective study was performed in 80 patients (age range, 25 - 52 years; mean age, 41 years) undergoing uae with pva between march and august 2006.Forty patients received pva particles mixed with ketoprofen, and 40 received bland pva particles.Fifty-three patients who were asymptomatic 8 hours after embolization were discharged.Pain scores were compared during the first 8 hours after the procedure, at discharge, and the following day.The results were evaluated after 6 months.Results: eight hours after uae, 13 of the 40 patients in the group without ketoprofen (32%) reported severe or very severe pain, whereas none of the patients in the group receiving ketoprofen reported severe or very severe pain, as determined with a numeric pain score scale (p.0015).Nineteen of the 40 patients without ketoprofen (48%) were treated as inpatients, but only 10 in the ketoprofen group (25%) were treated as inpatients.The differences in the clinical outcome, as well in the uterus and fibroid sizes at discharge and at 6 months, were not statistically significant (p >.05).Conclusions: the use of pva particles mixed with ketoprofen resulted in a statistically significant reduction in pelvic pain during the first 8 hours after uae as compared to the use of pva alone.However, no significant differences in pain scores were seen after 8 hours.These findings may lead to a reduction in inpatient management for uae; however, further study of this approach is warranted.It was further corrected that all patient symptoms were procedure related, and is not related to contour procedure or the contour device.

Manufacturer Narrative

Corrections: h6 patient codes and impact codes were updated and b5 revised as the adverse event is not related to the contour device.(b)(6)."pelvic pain after uterine artery embolization: a prospective randomized study of polyvinyl alcohol particles mixed with ketoprofen versus bland polyvinyl alcohol particles." journal of vascular and interventional radiology 19.11 (2008): 1537-1542.

• 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; model farm road; cork MN ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15066300
• MDR Text Key: 296238568
• Report Number: 2134265-2022-07840
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

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: 07/21/2022
• 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): Hospitalization