MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number UNK-P-SLING-MENS

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Stroke/CVA (1770); Unspecified Infection (1930); Pneumonia (2011); Sepsis (2067); Thrombosis (2100); Urinary Tract Infection (2120)

Event Date 01/01/2008

Event Type  Injury  

Event Description

Per literature, it was reported that a retrospective cohort review was performed using the us multi-institutional database acs-nsqip (2008-2013) to evaluate the rate of 30-day complications in patients undergoing male urethral sling (mus) and artificial urinary sphincter (aus) placement.The complication rate was compared between 30 days after mus surgery and aus implantation for male stress urinary incontinence.The subjects were 1,205 surgical patients with male stress urinary incontinence.Of these, 597 were mus (101 diabetic patients) and 608 were aus (121 diabetic patients).Compared to the aus group, the mus group had a lower overall complication rate in the 30 days after surgery (2.8% vs 5.1% p=0.046), occurence of urinary tract infection (0.3% vs 2.0%, p=0.020), and reoperation rate (1.0% vs 3.0%, p<0.001).In both groups, high bmi was associated with a higher risk of complications 30 days after surgery (p=0.0003).Other demographic variables and comorbidities were not associated with complications during the 30 days after surgery.Other complications observed within the first 30 days of implant included pneumonia (0.3% vs 0.2%, p=0.490), wound dehiscence (0.2% vs 0.2%, p=0.990), surgical site infection (1.0% vs 1.2%, p=0.810), prosthesis failure (0% vs 0.2%, p=0.320), myocardial infarction/cardiac arrest (0% vs 0.5%, p=0.090), unplanned intubation (0% vs 0.2%, p=0.320), pulmonary embolism (0.2% vs 0%, p=0.310), deep vein thrombosis/thrombophlebitis (0.2% vs 0.5%, p=0.330), stroke with neurological defect (0.2% vs 0%, p=0.310), acute renal failure (0% vs 0.3%, p=0.160), bleeding transfusions (0% vs 0.3%, p=0.10), and sepsis (0.2% vs 0.8%, p=0.110).Out of the 1,205 patients, there was one 30-day mortality death of an aus patient; the cause of death was not reported.Complication rates for both male sling and aus are low, while male sling exhibited a lower complication rate.Comparison of complication rates related to male urethral slings and artificial urinary sphincters for urinary incontinence: national multi-institutional analysis of acs-nsqip database.[int urol nephrol (2016) 48:1571-1576] doi: 10.1007/s11255-016-1347-3/ this report is for the sling devices.

• Brand Name: AMS SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 9242067
• MDR Text Key: 177372432
• Report Number: 2183959-2019-67009
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• 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; Required Intervention