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

Model Number UNK-P-SLING-MENS ADVANCE

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Urinary Retention (2119); Impaired Healing (2378)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

Per literature, it was reported that a retrospective evaluation was performed upon a (b)(6) study on risk factors of complications after the procedure targeting the 1019 male patients with stress urinary incontinence in which artificial urethral sphincter (aus: 506 cases including 265 single cuff (sc) and 217 double cuff (dc) ams800) and/or male sling (ms: 513 cases including 109 advance and 185 advance-xp) implanted between 2010 and 2012 were reviewed.Complications observed due to these ams800 include 62 sc cases and 36 dc cases for removal for unspecified reasons, 20 sc cases and 13 dc cases for infection, and 27 sc cases and 12 dc cases of de novo urge incontinence.Additional complications include urethral erosion (40 cases sc, 19 cases dc), dislocation of the device (11 sc, 7 dc), impaired wound healing (11 sc, 2 dc), pain (18 sc, 12 dc), bleeding (16 sc, 15 dc), acute urinary retention (32 sc, 32 dc), and mechanical failure (10 sc, 9 dc).A total of 64 complications were observed between the advance and advance-xp ms including 5 cases removal for unspecified reasons, 22 cases de novo urge incontinence, 7 cases dislocation of the device, 2 cases impaired healing, 5 cases of pain, and 23 cases of acute urinary retention.In the univariate analysis, pelvic irradiation history has a risk factor for aus or ms removal, and for aus, history of urethral stricture and severity of asa classification were also risk factors.In the multivariate analysis, pelvic irradiation history was an independent risk factor for aus or ms removal, and for aus, pelvic irradiation history, urethral stricture history, and diabetes were the independent predictors of urethral erosion and impaired wound healing respectively.In both univariate / multivariate analyses, infection and transfer of components were not an independent predictor.Risk factors for failure of male slings and artificial urinary sphincters: results from a large middle european cohort study [urol int 2017;99:14-21].Doi: 10.1159/000449232.This report is for the advance devices.

• Brand Name: AMS ADVANCE 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: 9192197
• MDR Text Key: 162691980
• Report Number: 2183959-2019-66833
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-SLING-MENS ADVANCE
• Device Catalogue Number: UNK-P-SLING-MENS ADVANCE
• 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