MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Obstruction/Occlusion (2422); Urinary Incontinence (4572)

Event Date 04/01/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid - urethral sling system device was implanted into the patient during a rigid cystoscopy + insertion of retropubic mid urethral sling procedure performed on (b)(6) 2016 for the treatment of stress urinary incontinence.At operation, it was noted that the patient had significant prolapse with a stage 2 cervical prolapse in addition to a stage 2 cystocele to the same level.During the procedure, the small trocar of the mesh injured the right side of the bladder neck, so it had to be removed and replaced.Mesh was inserted and repeat cystoscopy was performed at bladder capacity.Subsequently, the mesh was placed in good position.Patient was advised to return in couple of weeks.On (b)(6) 2016, patient had a revision surgery due to obstructed voiding.The urethra was observed to be tight with passage of scope.It was noted that the mesh sling was in good position at mid urethra but narrowed consistent with being under tension.The physician reported that the mesh was difficult to identify and eventually felt as a tight band which was well incorporated into the tissue.A 5mm segment of mesh was excised.Findings showed stage 2 apical prolapse and anterior prolapse to hymenal remnant.On (b)(6) 2016, patient had rigid cystoscopy, anterior vaginal repair, bilateral ssf, rectus fascial sling, urethral repair and left retrograde pyelography procedures for sui and stage 2 cervical prolapse.There was scarring around urethra and bladder and a hole on the right lateral side of mid urethra was identified.The physician decided to abandon plans for mid - urethral mesh sling for urethral repair and use the rectus fascial sling to correct sui and aid repair urethra in layers.On (b)(6) 2017, patient was admitted undergoing rigid cystoscopy + eua + urethral dilation + removal of urethral mesh with laser.She was, preoperatively, diagnosed with urinary retention post rectus fascial sling placement and postoperatively diagnosed with urethral mesh erosion.It was noted that there was an obvious mesh erosion posterior wall of urethra right side - mid urethra.It was planned that if the patient could not void after urethral dilatation, urethrolysis plus mesh excision at the same operation would be required.Otherwise, would leave the residual mesh in distal ureter with a view to further laser.In the physician assessment, mesh erosion was likely secondary to trauma from recurrent clean intermittent self - catheterization.On (b)(6) 2017, rigid cystoscopy + division of autologous sling / partial urethrolysis + removal of urethral mesh + urethroplasty was performed due to mesh in urethra and obstructed voiding.Rectus fascial sling was dissected off bladder neck to get better access and eventually, mesh was found on the right, narrow strip, 2cm of mesh was removed.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This complaint was received as litigation from a legal source in australia.Initial reporter info: (b)(6).Imdrf patient codes e2006, e2328, e2114, e1715 and e1309 capture the reportable events of obvious mesh erosion posterior wall of urethra, partial urethrolysis and obstructed voiding, hole on the right lateral side of mid urethra, and scarring around urethra and bladder, and urinary retention.Imdrf impact codes f1905 and f1901 capture the reportable events of 2cm of mesh was removed, and division of autologous sling/partial urethrolysis and urethroplasty.

• Brand Name: LYNX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16501538
• MDR Text Key: 310863101
• Report Number: 3005099803-2023-01137
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2023
• 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): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female