BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Device Problem
Positioning Problem (3009)
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Patient Problems
Erosion (1750); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Obstruction/Occlusion (2422); Urinary Incontinence (4572)
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Event Date 04/01/2016 |
Event Type
Injury
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Event Description
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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.
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Manufacturer Narrative
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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.
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