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

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Fibrosis (3167); Dyspareunia (4505)

Event Date 04/15/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system was impalnted during a solyx sling implant with cystoscopy procedure performed on (b)(6) 2010 to treat a patient with mixed urinary incontinence with predominant stress component.Operative findings include first degree cystocele with downward rotated urethra.It was noted that the bladder contour was appearing normal with no mucosal abnormalities of the bladder.The patient was transferred to the recovery room in stable condition and there were no patient complications reported at the conclusion of the procedure.On (b)(6) 2010, the patient experienced sling site pain.The patient underwent a sling revision with cystoscopy procedure.Operative findings include a good urethral support by the previously placed sling.Exploration of the right incision site of the sling revealed a fibrotic and hard area consistent with a sling dart displacement.Fibrotic tissue was dissected bluntly and the edge of the sling was grasped and the dart retracted medially with gentle and constant pressure, allowing removal of the dart.The edge of the remaining sling was found to have nice fibrosis around its edges and a 3-0 vicryl suture was placed in interrupted placement x2 in this area to secure the sling to the subfascial tissue.3-0 chromic suture was then utilized to close the incision.The cystoscopy revealed normal bladder contour without abnormalities.Hemostasis was excellent during the procedure.The patient was then taken to the recovery in stable condition.And there were no patient complications reported at the conclusion of the procedure.On (b)(6) 2012, the patient experienced vaginal pain and dyspareunia.The patient underwent a sling revision and cystourethroscopy procedure.Cystoscopy, before and after the procedure, revealed that there was no evidence of mass in the bladder nor any evidence of mesh erosion into the bladder or urethra, and no injury to bladder or urethra during surgery.The sling was noted to be just distal to the mid-urethra.The sling was divided in the midline, and the sling was dissected out to the obturator membrane bilaterally and removed.The patient was then taken to the recovery room in stable condition.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2010, initial revision procedure date, as no event date was reported.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting surgeon and initial revision procedure surgeon is dr.(b)(6).Second revision surgery performed by dr.(b)(6).Device code a0501 captures the reportable event of carrier detachment.Patient code e2330 captures the reportable event of pain.Patient code e1405 captures the reportable event of dyspareunia.Patient code e2313 captures the reportable event of fibrosis.Impact code f1905 captures the reportable event of revision surgery performed.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16470058
• MDR Text Key: 310591337
• Report Number: 3005099803-2023-01016
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/02/2023
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female