MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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

Patient Problems Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Hematuria (2558); Dysuria (2684); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2023

Event Type  Injury  

Event Description

It was reported to boston scientific, via the attached article published in the journal of endourology, the study results from a multicenter randomized control trial study.The study compared the sexual and urinary outcomes of rezum water vapor therapy procedures in two patient groups.Five-year outcomes demonstrated significant and durable urinary and sexual function results in the selected patients.Of the 426 patients who met the main study criteria (no history of urinary retention or previous prostate surgery for benign prostatic obstruction (bpo); post void residual [pvr] less than or equal to 250 ml; prostate volume 30 and less than or equal to 80 ml; no use of antiplatelet or anticoagulant medication; and few comorbidities) two groups were created: 232 patients who matched the 5-year randomized controlled trial rct inclusion criteria (group a) and 194 patients who did not (group b).Patients in group b met at least one of the following rct exclusion criteria: large prostate, presence of indwelling catheter, bladder stone or cancer, antiplatelet or anticoagulant medications, and comorbidities.The overall complication rate between the two groups was similar and all were grade clavien i or ii with one case of blood transfusion in group b.Complications included retrograde ejaculation, de novo anejacultation, pain, hematuria, urinary frequency, dysuria, urinary urgency, urinary incontinence, urinary retention, and clot retention.Patients in group b had a higher american society of anesthesiologists score, prostate volume, and postvoid residual measurement.No difference was found in terms of preoperative international prostate symptom score, international index of erectile function, maximum urinary flow, and prostate-specific antigen.Longer operative time and higher number of vapor injections were required in group b, with no differences in hospital stay, injection density, or complication rates.All urinary outcomes improved at 3, 6, and 12 months; at the last follow up, no differences were found in urinary outcomes between the two groups.All sexual outcomes improved with no differences between the two groups.The reintervention rate at the latest follow-up visit was 2.6% in group a and 3.1% in group b.The study concluded that water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patient comorbidities.No intraoperative adverse events were reported at the time the article was published.

Manufacturer Narrative

Correction: g2 report source- literature.H10 additional mfr narrative- citation.Cindolo, l.(2023).Do patients treated with water vapor therapy and meeting randomized clinical trial criteria have better urinary and sexual outcomes than an unselected cohort?.Journal of endourology, 37, 323-329.There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risks associated with implants of these devices as indicated in the instructions for use (ifu).The devices are not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported to boston scientific, via the attached article published in the journal of endourology, the study results from a multicenter randomized control trial study.The study compared the sexual and urinary outcomes of rezum water vapor therapy procedures in two patient groups.Five-year outcomes demonstrated significant and durable urinary and sexual function results in the selected patients.Of the 426 patients who met the main study criteria (no history of urinary retention or previous prostate surgery for benign prostatic obstruction (bpo); post void residual [pvr] less than or equal to 250 ml; prostate volume > 30 and less than or equal to 80 ml; no use of antiplatelet or anticoagulant medication; and few comorbidities) two groups were created: 232 patients who matched the 5-year randomized controlled trial rct inclusion criteria (group a) and 194 patients who did not (group b).Patients in group b met at least one of the following rct exclusion criteria: large prostate, presence of indwelling catheter, bladder stone or cancer, antiplatelet or anticoagulant medications, and comorbidities.The overall complication rate between the two groups was similar and all were grade clavien i or ii with one case of blood transfusion in group b.Complications included retrograde ejaculation, de novo anejacultation, pain, hematuria, urinary frequency, dysuria, urinary urgency, urinary incontinence, urinary retention, and clot retention.Patients in group b had a higher american society of anesthesiologists score, prostate volume, and postvoid residual measurement.No difference was found in terms of preoperative international prostate symptom score, international index of erectile function, maximum urinary flow, and prostate-specific antigen.Longer operative time and higher number of vapor injections were required in group b, with no differences in hospital stay, injection density, or complication rates.All urinary outcomes improved at 3, 6, and 12 months; at the last follow up, no differences were found in urinary outcomes between the two groups.All sexual outcomes improved with no differences between the two groups.The reintervention rate at the latest follow-up visit was 2.6% in group a and 3.1% in group b.The study concluded that water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patient comorbidities.No intraoperative adverse events were reported at the time the article was published.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16877782
• MDR Text Key: 314655771
• Report Number: 2124215-2023-21963
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male