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

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

Patient Problems Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Sexual Dysfunction (4510); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: article publication date used.Initial reporter facility name: department of urology, school of medicine, university of st.Gallen.

Event Description

It was reported via a journal article that patient complications occurred.Abstract: background: prostatic artery embolisation (pae) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (luts/bpo) still remains under investigation.Objective: to compare the efficacy and safety of pae and transurethral resection of the prostate (turp) in the treatment of luts/bpo at 2 yr of follow-up.Design, setting, and participants: a randomised, open-label trial was conducted.There were 103 participants aged greater than or equal to 40 yr with refractory luts/bpo.Intervention: pae versus turp.Outcome measurements and statistical analysis: international prostate symptoms score (ipss) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated.Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests.Results and limitations: the mean reduction in ipss after 2 yr was 9.21 points after pae and 12.09 points after turp (difference of 2.88 [95% confidence interval 0.04 - 5.72]; p = 0.047).Superiority of turp was also found for most other patient-reported outcomes except for erectile function.Pae was less effective than turp regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of -6.33 [-10.12 to -2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31 - 240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70 - 31.38]; p = 0.005).Adverse events were less frequent after pae than after turp (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar.Ten patients (21%) who initially underwent pae required turp within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and therefore, represents a limitation of the study.Conclusions: inferior improvements in luts/bpo and a relevant re-treatment rate are found 2 yr after pae compared with turp.Pae is associated with fewer complications than turp.The disadvantages of pae regarding functional outcomes should be considered for patient selection and counselling.

Manufacturer Narrative

Correction - h6 updated to: skin inflammation/irritation and sexual dysfunction.B3 - date of event: article publication date used.E1 - initial reporter facility name: (b)(6).

Event Description

It was reported via a journal article that patient complications occurred.Abstract: background: prostatic artery embolisation (pae) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (luts/bpo) still remains under investigation.Objective: to compare the efficacy and safety of pae and transurethral resection of the prostate (turp) in the treatment of luts/bpo at 2 yr of follow-up.Design, setting, and participants: a randomised, open-label trial was conducted.There were 103 participants aged greater than or equal to 40 yr with refractory luts/bpo.Intervention: pae versus turp.Outcome measurements and statistical analysis: international prostate symptoms score (ipss) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated.Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests.Results and limitations: the mean reduction in ipss after 2 yr was 9.21 points after pae and 12.09 points after turp (difference of 2.88 [(b)(4) confidence interval 0.04 - 5.72]; p = 0.047).Superiority of turp was also found for most other patient-reported outcomes except for erectile function.Pae was less effective than turp regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of -6.33 [-10.12 to -2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31 - 240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70 - 31.38]; p = 0.005).Adverse events were less frequent after pae than after turp (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar.Ten patients ((b)(4)) who initially underwent pae required turp within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and therefore, represents a limitation of the study.Conclusions: inferior improvements in luts/bpo and a relevant re-treatment rate are found 2 yr after pae compared with turp.Pae is associated with fewer complications than turp.The disadvantages of pae regarding functional outcomes should be considered for patient selection and counselling.

• 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: 15176425
• MDR Text Key: 297350801
• Report Number: 2134265-2022-08386
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 08/24/2022

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: 08/17/2022
• 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