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); Pain (1994); Impaired Healing (2378)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2016, first revision procedure date, as no event date was reported.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Initial reporter name and address: (b)(6).(b)(4).

Event Description

Note: this report pertains to one of two devices implanted into the same patient.Refer to manufacturer report # 3005099803-2022-05050 for the associated device information.It was reported to boston scientific corporation that a solyx sis system was used during a rectocele repair, perineal repair, bilateral sacrospinous ligament fixation, solyx mid urethral sling implant, and cystoscopy procedures performed on (b)(6) 2016 to treat a patient with rectocele, perineocele and uterine prolapse as well as stress urinary incontinence and painful menstrual cycles.The patient underwent a concomitant laparoscopic vaginal hysterectomy by a different surgeon just prior to this procedure.There were no complications during the (b)(6) 2016 implant procedure.Three months after the procedure, the patient had an exposure of transvaginal mesh/mid urethral sling and an area on the anterior vaginal wall (about 3 mm long x 6 mm wide) which had not healed.In the physician's assessment, the wound healing was impaired due to the patient's history of smoking and continued use despite recommendations to quit.The patient also failed to use her vaginal estrogen cream post operatively as recommended.The last six weeks, however, the patient had been using a compound estrogen cream after the mesh exposure was identified.In the physician's assessment, this had failed to resolve the problem.The patient was having vaginal pain associated with the mesh exposure so a decision was made for the patient to undergo revision of transvaginal mesh with xenform soft tissue matrix biologic interposition graft (2 cm x 1 cm in dimension) procedures.On (b)(6) 2016, during the revision of transvaginal mesh with xenform soft tissue matrix biologic interposition graft (2 cm x 1 cm in dimension) procedures, after consent was obtained, the patient was brought to the operating room where she was put to sleep under general anesthesia after scds had been placed.The patient was administered with iv gentamycin.She was moved to the dorsal lithotomy position where she was clipped and then prepped and draped in the usual sterile fashion.The physician started by placing a foley catheter to drain the patient's bladder.A lone star retractor was then placed with six blue hooks to give adequate vaginal exposure.The area of the exposed mesh was seen at the distal portion of the mid urethra.It was measured to be 3 mm long and 6 mm wide.A local anesthetic of 0.25% marcaine with epinephrine was infiltrated around the vaginal epithelial edges.Metzenbaum scissors were used to very finely create a plane between the vaginal epithelium and the exposed mesh.The physician developed the flaps out towards the obturator and internus fascia on each side and more proximally heading up towards the bladder and as far distally as possible towards the urethral meatus so that there would be no tension on the vaginal epithelial closure.Formed biologic graft was then soaked in saline for about five minutes until it turned gray.The area of tissue plane was measured that the physician had dissected and this was about 3 cm wide by 1.5 cm long.The area of exposed mesh was much smaller than this.The physician therefore cut a piece of xenform about 2 cm wide x 1 cm long to adequately cover the mesh exposure and give the physician a good overlapping graft placement for closure of the epithelial skin.Using a #3-0 vicryl stitch on an rb1 needle, the graft was tethered to the periurethral fascia in all four corners well away from the mesh.The body of the graft overlaid the exposed mesh.This area was irrigated with gu irrigant and then the vaginal epithelium was closed with a running #3-0 vicryl stitch.The area was again irrigated with gu irrigant and the physician gave her 10 more ml periurethral block using marcaine.A vaginal packing was placed at the end of the case.The packing was to be removed 45 minutes later in pacu.The foley catheter was removed at the end of the case.The patient tolerated the procedure well and was able to be awoken, extubated, and transferred to pacu in good condition.The patient was instructed for follow up in the outpatient urology clinic three weeks post procedure.A prescription for tylenol #3 for pain, 1 bactrim-ds oral two times a day for three days for urinary tract infection and wound infection prevention.On (b)(6) 2016, the patient could feel a very small portion of the tines of the mesh in the lateral crevices of the area of vaginal mesh exposure.The vaginal wall was not granulating well.After consent was obtained for an excision of transvaginal mesh, repair of vaginal defect and cystoscopy procedures, the patient was brought to the operating room where shad scds placed and was put to sleep under general anesthesia.The patient was administered with iv gentamycin and ancef.She was sterilely prepped and draped after all pressure points were padded.The betadine from the prep was washed away with normal saline.The edges of the vaginal mucosa were grasped and palpated for any mesh.The physician was able to palpate mesh a few times on the patient's right side down towards the lateral crevice were the previous midline incision had broken down.On the left side, the physician was not able to palpate much mesh initially.Using scissors, the physician made an inverted u based incision into the vaginal wall and dissected down a flap of tissue along the anterior vaginal wall, more cephalad.There seemed to be a capsule of tissue from the previous healing present.Up into the right lateral crevice towards the obturator internus membrane, a plane of dissection was created between the vaginal mesh and the skin.The physician was then able to easily grasp the tines of the vaginal mesh which was then cut back all the way towards the obturator internus on that side.On the left side, the physician could really not ever find any remaining vaginal mesh.The area was copiously irrigated first with gu irrigant and then followed with just normal saline.The vaginal wall flap was advance distally to cover the vaginal defect.Using #3-0 vicryl stitches in an interrupted fashion, the edges of the vaginal skin from the u flap were anastomosed to the vaginal mucosa up toward the urethral meatus and back laterally towards the crevices on each side, completely closing the problem.A few mattress stitches were placed to close any dead space between the vaginal wall flap and the periurethral fascia.Cystourethroscopy was then performed after removing the foley catheter to ensure that there had been no inadvertent urethral injury.This was normal.The bladder was entered, fully surveilled and was also normal.The bladder was drained and the catheter was left out.The vagina was then packed with a moist kerlix.The patient was able to be awoken, extubated, and transferred to pacu in good condition.Vaginal packing was to be removed an hour post procedure.The patient would need to void prior to discharge.The patient was instructed for follow up in the next few weeks post procedure.The patient was advised not to do heavy lifting or gross physical activities such as running, squatting, jumping, or lifting more than 10 pounds.The patient was also advised to refrain from intercourse for the next six weeks post procedure.The patient will have to continue to use her vaginal estrogen.The patient was also advised to consume 1-2 protein or nutritional shakes per day.

• 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: 15417297
• MDR Text Key: 299846610
• Report Number: 3005099803-2022-05051
• 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
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female