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

Model Number M0068507000

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

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Hemorrhage/Bleeding (1888); Prolapse (2475); Urinary Incontinence (4572)

Event Date 11/15/2013

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2013, the date of the second sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Patient codes capture the reportable events of erosion (mesh erosion through the vaginal wall and through the distal urethra), fistula (urethrovaginal fistula), and calcium deposits/calcification (2mm calcification on the mesh), respectively.Impact codes capture the reportable events of additional surgery (posterior colporrhaphy, insertion of graft for correction of pelvic support defect, axis-sub-urethral placement, urethroplasty, and cystoscopy), and device revision or replacement (lynx transvaginal sling), respectively.Conclusion code is being used in lieu of an adequate conclusion code for device not returned.The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to one of two devices implanted into the same patient.It was reported to boston scientific corporation that a solyx single incision sling system was implanted during a solyx mid-urethral sling procedure performed on (b)(6) 2013, for the treatment of stress urinary incontinence.The patient has had problems with stress incontinence secondary to urethral hypermobility.At cystoscopy, the bladder examination was normal, and she had a positive marshall test with significant leakage with coughing, which was correctable by elevation of the periurethral vaginal wall.Options, risks, and potential complications were discussed with her at length, and at this point, she wants to proceed with the placement of a sling for correction of her stress incontinence.She fully understands the nature of the risks and potential complications, such as infection and urinary retention.She has received ancef and gentamicin preoperatively.On (b)(6) 2013, a lynx suprapubic mid-urethral sling system was implanted during a lynx transvaginal sling procedure for the treatment of stress incontinence.The patient had previously undergone the solyx mid-urethral sling procedure on (b)(6), with resolution of her stress incontinence.She was seen and was doing well but was seen back in september with a recurrence of incontinence, which was followed by an asthma attack.She was using 1 pad per day.Repeated testing showed urethral hypermobility and a positive marshall test; a small amount of leakage in the lithotomy position was correctable with elevation.She wanted to proceed with the insertion of another sling.The patient and the doctor talked about using a transvaginal sling for a longer period of success.She understood the nature of the procedure, its risks, and potential complications, including retention and instability.During the procedure, there was minimal bleeding throughout the procedure, and then the incision was closed with 2-0 running vicryl.The suprapubic ends of the slings were transected below skin level, and the small suprapubic incisions were closed with derma bond.The tegaderm dressing was applied, the 18-french foley catheter was replaced, and the patient was awakened and taken to the recovery room in stable condition.On (b)(6), the patient underwent posterior colporrhaphy, insertion of graft for correction of pelvic support defect (axis-suburethral placement), urethroplasty, and cystoscopy procedure.The patient had cystocele and rectocele, mesh erosion through the vaginal wall and through the distal urethra, and urethrovaginal fistula.According to the findings from cystoscopy, the bladder mucosa was normal, and there was a bilateral ureteral efflux at the conclusion of the procedure.There was no evidence of a foreign body or trauma within the bladder.On initial inspection, there was a mesh exposure bilaterally through the vaginal wall at the suburethral region.A small, 2mm calcification was present on the mesh.The distal portion of the mesh was still intact across the midline, though it appeared the proximal majority of the mesh was separated.The area that was intact had clearly eroded through the distal urethra, and an underlying urethral defect was noted.This was seen clearly on cystoscopy and exam under anesthesia at the start of the procedure.The rectum and vagina were intact at the end of the procedure with no foreign body or trauma within the vagina or rectum.The procedure was then completed, and the patient was transferred in a stable and awake condition.Also, she did receive peri-operative antibiotics.

Event Description

Note: this manufacturer report pertains to one of two devices implanted into the same patient, the solyx single incision sling system was implanted into the patient on (b)(6)2013.It was reported to boston scientific corporation that a solyx single incision sling system was implanted during a solyx mid-urethral sling procedure performed on (b)(6) 2013, for the treatment of stress urinary incontinence.The patient had been having problems with stress incontinence secondary to urethral hypermobility.At cystoscopy, the bladder examination was normal, and she had a positive marshall test with significant leakage with coughing, which was correctable by elevation of the periurethral vaginal wall.She received ancef and gentamicin preoperatively.The patient had been doing well after the solyx implantation, but was seen in (b)(6) 2013 with a recurrence of incontinence following an asthma attack.She was using 1 pad per day.Repeated testing showed urethral hypermobility and a positive marshall test; a small amount of leakage in the lithotomy position was correctable with elevation.She wanted to proceed with the insertion of another sling.On (b)(6) 2013, a lynx suprapubic mid-urethral sling system was implanted during a lynx transvaginal sling procedure for the treatment of stress incontinence.During the procedure, there was minimal bleeding, and the incision was closed with 2-0 running vicryl.The suprapubic ends of the slings were transected below skin level, and the small suprapubic incisions were closed with derma bond.The tegaderm dressing was applied, the 18-french foley catheter was replaced, and the patient was awakened and taken to the recovery room in stable condition.On (b)(6) 2021, the patient underwent posterior colporrhaphy, insertion of graft for correction of pelvic support defect (axis-suburethral placement), urethroplasty, and cystoscopy procedure.The patient had cystocele and rectocele, mesh erosion through the vaginal wall and through the distal urethra, and urethrovaginal fistula.According to the findings from cystoscopy, the bladder mucosa was normal, and there was a bilateral ureteral efflux at the conclusion of the procedure.There was no evidence of a foreign body or trauma within the bladder.On initial inspection, there was a mesh exposure bilaterally through the vaginal wall at the suburethral region.A small, 2mm calcification was present on the mesh.The distal portion of the mesh was still intact across the midline, though it appeared the proximal majority of the mesh was separated.The area that was intact had clearly eroded through the distal urethra, and an underlying urethral defect was noted.This was seen clearly on cystoscopy and exam under anesthesia at the start of the procedure.The rectum and vagina were intact at the end of the procedure with no foreign body or trauma within the vagina or rectum.The procedure was then completed, and the patient was transferred in a stable and awake condition.She received peri-operative antibiotics.

Manufacturer Narrative

Correction to block b5.Block b3 date of event: date of event was approximated to november 15, 2013, the date of the second sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6) the revision surgeon is: (b)(6) block h6: patient codes e2330, e2314 and e230901 capture the reportable events of erosion/extrusion (mesh erosion through the vaginal wall and through the distal urethra/ mesh exposure bilaterally through the vaginal wall), fistula (urethrovaginal fistula), and calcium deposits/calcification (2mm calcification on the mesh), respectively.Impact codes f1901 and f1905 capture the reportable events of additional surgery (posterior colporrhaphy, insertion of graft for correction of pelvic support defect, axis-sub-urethral placement, urethroplasty, and cystoscopy), and device revision or replacement (lynx transvaginal sling), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14750768
• MDR Text Key: 294403147
• Report Number: 3005099803-2022-03387
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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
• Device Expiration Date: 03/31/2013
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 1ML0030203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female