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

Model Number M0068507001

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Prolapse (2475); Urinary Incontinence (4572)

Event Date 07/20/2011

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of explant of sub-urethral sling.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling (sis) system was implanted into the patient during a solyx mid-urethral sling with polypropylene mesh and total laparoscopic hysterectomy, bilateral salpingo-oophorectomy procedure performed on (b)(6) 2011, to treat stress urinary incontinence, abnormal perimenopausal bleeding and persistent bilateral ovarian cyst.The operative report notes the uterus was enlarged about 8 to 10 weeks in size.Also, there were bilateral simple ovarian cysts.Otherwise, unremarkable adnexa.Based on the pathology specimen report for this procedure, the patient's final diagnosis was adenomyosis, follicular cyst of right ovary, left benign paratubal cysts, squamous metaplasia of cervix, benign non-hyperplastic endometrium, and right ovary and bilateral tubes without significant abnormality.On (b)(6) 2020, the patient underwent bilateral sacrospinous fixation of vaginal vault suspension, enterocele repair, and rectocele repair, all with biologic graft.Additionally, the patient underwent explantation of sub-urethral sling, urethrolysis, urethral repair, retropubic collagen sling, and cystoscopy with calibration.The preoperative diagnoses were listed as vaginal vault prolapse, vaginal prolapse, urethral sling erosion, and stress urinary incontinence with urethral hypermobility.Firstly, the patient was taken to the operating room and was induced with general anesthesia.Then, prophylactic antibiotics were given, and she was sterilely prepped and draped in the high lithotomy position in usual fashion.Attention was turned towards the posterior vagina, where a vertical incision was made in the posterior vagina to approximately 3 cm inferior to the vaginal apex.The vaginal mucosa was dissected off the underlying pelvic tissues to the level of the vaginal sulcus.Perirectal spaces were entered bluntly, exposing the ischial spines on all aspects to sacrospinous ligaments bilaterally.The vaginal vault suspension was then performed.The body of the graft was then secured to the vaginal vault with 3 interrupted 0 vicryl sutures 1 and the 0 prolene sutures were passed through the apical arms into the right location and tied down giving excellent vaginal vault support.Posterior vagina was closed to its midportion with running 2-0 caprosyn suture in a nonlocking fashion.Attention was then turned towards the anterior vagina.A vertical incision was made in the anterior vagina about 1.5 cm long under the mid urethra.The vaginal mucosa was dissected off the overlying pelvic tissues to the level of vaginal sulcus and urogenital diaphragm bilaterally.The previously placed sling was then identified, gently grasped, and dissected away from the surrounding vaginal periurethral tissues and divided the midline.The left side was dissected out to the level of the inferior ramus and removed at that level.On the right side, the sling was noted to be eroding into the urethra.This was gently dissected free completely ensuring there was no mesh within the urethral lumen and out to the inferior ramus and removed at that level leaving approximately 1 cm defect in the right midline of the mid urethra.The edges of the defect were clearly identified and there was no remaining mesh.Prior to the urethral repair, urethrolysis had been performed to fully mobilize the urethra.The retropubic collagen sling was then performed.A 2 cm transverse incision was created immediately superior to the pubic symphysis after being infiltrated with 1% lidocaine with epinephrine.This was carried down to the level of the rectus fascia.Moreover, stamey needles were inserted through the skin incision into the ipsilateral space of retzius and onto the operator's finger and the vaginal incision at the level of the mid urethra.This was performed bilaterally.Cystoscopy with calibration was then performed.The foley catheter was removed, and a 17-degree scope was inserted into the bladder.Bladder was filled about 300 ml to visualize the bladder structures well.There was no bleeding or injury to the bladder.However, there was bilateral efflux of urine from both orifices.Urethra was also carefully inspected, where the urethral repair was noted to be well closed with no remaining problem and no evidence of persistent mesh within the urethra.The patient's urethra and bladder were calibrated with a 17-french.Then the scope was removed and a foley catheter was placed.Furthermore, the bladder was drained, and the sling was then completed with a 2x6 collagen sling with attached 0 pds suture that was brought into the vaginal incision.The stamey needles were used to bring 0 pds sutures into the abdominal incision.Sling was then secured in the midline with interrupted 2-0 vicryl suture and then appropriately tensioned, being tied down in the abdominal incision.The wounds were then irrigated.The vaginal epithelial incision was closed with a 2-0 caprosyn in a nonlocking fashion.Moreover, the abdominal wound was closed in the deep dermis with interrupted 2-0 vicryl sutures, and skin incisions were closed with a 4-0 monocryl in subcuticular fashion and covered with dermabond.Attention was then returned to the posterior vagina, and the vaginal enterocele repair with graft was performed.The posterior tail of the graft was anchored to the iliococcygeus and mid vagina with 2 interrupted 0 vicryl sutures.The tail was then anchored to the perineal body with 3 interrupted 0 vicryl sutures.This recreated the rectovaginal septum and completed vaginal enterocele repair with grafts.The rectocele repair was then performed.The endopelvic fascia overlying levators were plicated in the midline with interrupted 0 vicryl suture.In addition, the transperineal bulbocavernosus muscles were also plicated in the midline for a perineoplasty.The posterior vagina was closed with running 2-0 caprosyn suture in a nonlocking fashion.Following the procedure, the patient's vagina was packed with metrogel soaked with gauze, and rectal exam was performed.She also was checked for any bleeding or injury and was turned to supine position in stable condition, having tolerated the procedure well and was transposed to the post-anesthesia care unit.

• 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: 12866630
• MDR Text Key: 285616263
• Report Number: 3005099803-2021-05966
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2021

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: 12/31/2013
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: 1ML0121301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Race: White