MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994)

Event Date 01/07/2019

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted during a mid-urethral sling procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence.After the procedure, the cystoscopic evaluation showed no urethral or bladder injury.On (b)(6) 2022, the patient was diagnosed with mesh erosion and stress incontinence and had removal of eroded mesh with autologous pubovaginal sling.Findings: the mesh had exposed itself through the midline.Cystoscopy that was performed after the sling placement showed no urethral or bladder injury.Description of procedure: the eroded sling was noted and dissected from sidewall to sidewall.After removing the sling, the vaginal planes were further developed for the placement of the pubovaginal sling.A 2 cm x 7 cm facia was harvested from the rectus abdominis.The fascia was then attached and then pulled into the vaginal field.At this point, cystoscopy was performed showing no urethral or bladder injury.The sling was tied in the midline in a tension-free way.Each portion of the sling went into the space of retzius.The wound was then closed in two layers.There were no immediate complications.On (b)(6) 2023, the patient was diagnosed with painful vaginal nodule and the retained vaginal mesh was excised.Operative findings: the painful nodular area was confirmed preoperatively with the patient.This was a remnant of the previous vaginal mesh that was placed for stress incontinence.The patient was aware that stress incontinence could come back once the procedure was done; however, the nodule was creating lifestyle limitations.The mesh was removed only on the right side out to the level of its insertion point at the inferior ramus.Postop examination did not reveal any nodular hardened areas.The bladder was irrigated and there was no suggestion of bladder damage.Cystoscopy was not performed as it was not deemed necessary.Description of the procedure: there was a slight area of mesh exposure.The area around the mesh was dissected.Dissection continued back to the level of the inferior ramus using both sharp and blunt dissection.At this point, the physician excised at the level posterior to the ramus.Palpation revealed a hardened area that was previously noted was no longer present.The defect was closed, and no leakage was noted when it was reirrigated.The skin mucosa was then closed, and a catheter was left in place.An estrogen-soaked vaginal pack was placed for tamponade and postoperative surgical management and would be removed in the morning.Palpation of the contralateral side did not show a similar finding.Palpation under the bladder and the urethra was unremarkable.The patient's condition during operation was stable.On (b)(6) 2023, surgical pathological report was performed, and it only showed the explanted vaginal mesh dimensions.The report noted that there was no tissue attached to the specimen collected.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.Block h6: imdrf patient code e2006 captures the reportable event mesh erosion.Imdrf patient code e2330 captures the reportable event pain.Imdrf patient code e2324 captures the reportable event of urinary incontinence.Imdrf impact code f1905 captures the reportable event device revision.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18582727
• MDR Text Key: 333772899
• Report Number: 2124215-2024-03087
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female