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

Model Number	M0068503000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of october 11, 2023, was chosen as a best estimate based on the date of mesh excision.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6) block h6: the following imdrf patient codes capture the reportable events of: e2006 - erosion e2330 - pain the following imdrf impact codes capture the reportable events of: f1903- vaginal mesh excision.
Event or Problem Description
It was reported that a lynx system was implanted to the patient.During the same procedure, cystoscopy was also performed which revealed normal appearing and no evidence of trauma to the bladder or to the urethra.On (b)(6) 2023, the patient was diagnosed with mesh erosion and pain in the bladder.She underwent robotic- assisted removal of sling mesh from bladder mucosa and muscularis with intentional cystotomy and repair, vaginal mid-urethral dissection, and cystourethroscopy.Operative findings revealed, when cystourethroscopy was performed, two to three centimeters of white sling mesh with entry and exit point in the left bladder wall in trajectory of retropubic sling trocar placement was noted.No bladder stones seen and the bladder mucosa was normal.No other mesh or foreign objects noted.One right and one left ureteral orifice in the normal anatomic position.The urethra with mesh exposure and urethroscopy were normal.Intraabdominal survey revealed filmy adhesions of omentum to abdominal wall at site of prior midline incision and right sidewall out of operative field and not taken down, otherwise intraabdominal survey was normal.When the bladder was taken down, the mesh was identified on the left in space of retzius, followed down to the bladder.When intentional cystotomy was created at site of mesh entry to bladder with cystoscopic assistance and traced to second mesh exit site of bladder, the mesh exited the bladder and coursed towards the vagina retropubic space; however, unable to palpate mesh vaginally even with traction.The mesh excised complete and no vaginal mesh was palpated after excision.Intentional cystotomy at left bladder dome, superior to trigone and urethra.Bilateral ureteral efflux noted at end of case.The bladder was closed in two layers.During the procedure, a three-centimeter incision was made in the anterior vaginal wall at the level of the mid urethra.The epithelium was dissected away from the underlying pubourethral fascia.The periurethral tunnels were also dissected bilaterally to the level of the pubic rami; however, there was no clear visualization of the mesh vaginally.The foley catheter was removed and cystoscopy was performed.The entire bladder and urethra were visualized with the mesh as it was noted to be through the bladder mucosa.There was efflux of urine from bilateral ureteric orifices.Foley catheter was replaced.The bladder was backfilled to identify the superior margin of the dome of the bladder and the monopolar scissors were used to open peritoneum superior to this point.At this point the bladder was drained, the space of retzius was identified and developed.When the bladder and perivesicular fat were dissected medially en bloc away from the lateral aspect of the anterior vaginal wall and the obturator internus muscle on each side, there was only one arm of mesh that was seen traversing above the pubic bone.An intentional cystotomy was then performed in order to be able to remove the mesh from the bladder mucosa.At this time, a 70-degree cystoscope was kept inside the bladder to confirm the direct path of the sling.In order to remove the sling in its entirety from the bladder mucosa, a four-centimeter cystotomy was created.Once the mesh was dissected from the mucosa, the remainder was dissected from the muscularis and taken down to the level of the vagina.This was likely the entire sling that had been placed and was moved into an abnormal position given the location within the bladder.Once the dissection of the sling was confirmed, the cut from the underlying tissue was removed from the abdomen and found to be eight-centimeter in length.There was no other sling that was identified within the abdominal or pelvic cavity and vagina.The bladder was visualized without injury to the urethra or ureters with bilateral ureteral jets.The cystotomy was closed and water tightness was confirmed after closure of the first layer.Hemostasis was ensured and noted throughout, and the peritoneum was closed.

• Brand Name: LYNX SYSTEM
• Common Device Name: 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20698454
• Report Number: 2124215-2024-70692
• Device Sequence Number: 3783249
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: ML00001780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female