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

Model Number M0068507000

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Fibrosis (3167); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6) 2019, date when the device was implanted.The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.This event was reported by the patient's legal representation.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2019.As reported by the patient's attorney, she suffered she suffered pelvic pain, dyspareunia, vaginal pain, erosion, urinary issues, and chronic complications of mesh, including inflammation and foreign body reaction.Moreover, the patient had to undergo multiple removal procedures.

Manufacturer Narrative

Block b3: date of event is approximated to (b)(6) 2019, date when the device was implanted.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Block h6: patient codes e2330, e2006, e1405, e2326 and e0402 captures the reportable events of pain, erosion, dyspareunia, scar tissue, inflammation, and allergic reation.Impact codes f12 and f1905 captures the reportable event of serious injury and device revision.Block h11: blocks a2, b5, e1 and h10 have been updated based on the additional information received on february 9, 2023.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2006 captures the reportable event of erosion.Patient code e2326 captures the reportable event of inflammation.Patient code e1311 captures the reportable event of kidney or urinary problem.Patient code e2330 captures the reportable event of pain.Patient code e0402 captures the reportable event of allergic reaction.Impact code f1905 captures the reportable event of device revision procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2019.As reported by the patient's attorney, she suffered she suffered pelvic pain, dyspareunia, vaginal pain, erosion, urinary issues, and chronic complications of mesh, including inflammation and foreign body reaction.Moreover, the patient had to undergo multiple removal procedures.The procedures performed on (b)(6) 2019 were total vaginal hysterectomy, bilateral salpingo-oophorectomy, uterosacral vault suspension, posterior repair, perineorrhaphy, single incision midurethral sling and cystoscopy to treat a patient with uterovaginal prolapse and stress urinary incontinence.Intraoperative findings include small atrophic uterus with cervical hypertrophy, normal adnexa, and normal cystoscopic findings.The patient was stable and in satisfactory condition at the conclusion of the procedure.There were no patient complications reported as a result of this procedure.

Manufacturer Narrative

B3, b5, b7, h6: impact codes, device codes, component codes, evaluation method codes, evaluation result codes and evaluation conclusion codes have been updated based on the additional information received on 09aug2023 and 15aug2023.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6); (b)(6) center united states.Block h6: patient codes e2330, e2006, e1405, e2326 and e0402 capture the reportable events of pain, erosion, dyspareunia, scar tissue, inflammation, and allergic reaction.Impact codes f12 and f1905 capture the reportable event of serious injury and device revision.Block h11: blocks a2, b5, e1 and h10 have been updated based on the additional information received on (b)(6) 2023.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6), md.(b)(6) center (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2006 captures the reportable event of erosion.Patient code e2326 captures the reportable event of inflammation.Patient code e1311 captures the reportable event of kidney or urinary problem.Patient code e2330 captures the reportable event of pain.Patient code e0402 captures the reportable event of allergic reaction.Impact code f1905 captures the reportable event of device revision procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Patient code e2328 captures the reportable event of bladder outlet obstruction.Patient code e2006 captures the reportable event of foreign body sensation.Patient code e2311 captures the reportable event of discomfort.Patient code e1309 captures the reportable event of posts void residual of 26ml.Patient code f2301 captures the reportable event of scar tissue.Impact code f1905 captures the reportable event of placement of urethral catheter by physician.Impact code f1903 captures the reportable event of complete removal of mesh.Patient code e0402 captures the reportable event of giant cell reaction to foreign material.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2019.As reported by the patient's attorney, she suffered she suffered pelvic pain, dyspareunia, vaginal pain, erosion, urinary issues, and chronic complications of mesh, including inflammation and foreign body reaction.Moreover, the patient had to undergo multiple removal procedures.Additional information received on february 9, 2023; the procedures performed on (b)(6) 2019, were total vaginal hysterectomy, bilateral salpingo-oophorectomy, uterosacral vault suspension, posterior repair, perineorrhaphy, single incision midurethral sling and cystoscopy to treat a patient with uterovaginal prolapse and stress urinary incontinence.Intraoperative findings include small atrophic uterus with cervical hypertrophy, normal adnexa, and normal cystoscopy findings.The patient was stable and in satisfactory condition at the conclusion of the procedure.There were no patient complications reported as a result of this procedure.Additional information received on august 9 and august 15, 2023: on (b)(6) 2019, the patient was seen to evaluate urgency incontinence.She underwent a total abdominal hysterectomy with bilateral salpingo-oophorectomy (tvh/bso), vault suspension anterior-posterior repair, and transobturator tape (tot) by another urogyn 6 weeks ago, and since the surgery, has had ache and discomfort in the bladder with the feeling fullness and markedly significant urgency.She feels that she always has to void.She feels like she is not emptying well, and the flow is slow.She has had a urinary tract infection (uti) recently.She denies vaginal bleeding.She has had at least one episode of stress urinary incontinence since the repairs.She has a feeling of fullness in the bladder.Pvr was checked by the doctor and was reportedly ok.She denies any gi symptoms.Impression/plan: the patient has sling complications, including urgency, and would like to undergo surgical correction of her problem.It was recommended to have a transvaginal excision of as much of the sling as possible.Visit diagnoses: erosion of suburethral sling, initial encounter.Bladder outlet obstruction.Urinary urgency.On (b)(6) 2019, the patient was diagnosed with complications of suburethral sling with urgency and partial obstruction of the urethra from sling and sling shrinkage.She then underwent a transvaginal excision of the sling.The vagina was dissected away from the sling bilaterally.The sling was found to be buried with a dense plate of scarring with significant bridging fibrosis and scar plating around the sling.The sling was carefully teased away from the urethra.The sling was found to partially occluding the urethra, and measurement of the sling showed the width of the sling prior to explant being approximately 0.6 cm in width, thus confirming that the sling had shrunk considerably from its implant width.The mid-portion of the sling was dissected free of the urethra, and a 2 cm portion of the sling was excised and sent to pathology.A note was made at this point that the surgeon could now appreciate relief from the partial obstruction of the urethra by the sling, and no more of the sling material was able to be removed.Per the physician, it was clear that the portion of the sling removed substantially diminished the adverse effect the sling was having on the mid-urethra.Another visit was done by the patient on (b)(6) 2020, through telemedicine.Patient with pelvic pain (muscle pulling sensation, foreign body sensation) post excision mid-urethral sling (b)(6) 2019.She is requesting to have it removed.No concerns, irritative/obstructive voiding symptoms, or incontinence.The physician had a lengthy conversation with the patient regarding her situation, and she continues to feel a bothersome pulling sensation that often progresses to pain in the groin region since her surgery and feels that the partial sling removal has not alleviated her symptoms.Additionally, she reports in notes dated (b)(6) 2020, new onset symptoms of a feeling of vaginal prolapse.She feels a potential prolapse at the level of the mid vagina upon self-examination and is wondering whether her vaginal prolapse is returning.Due to a painful remnant urethral sling, the patient had a transvaginal excision of the remnant solyx sling and cystourethroscopy on (b)(6) 2020.During the procedure, it was noted that the mesh carrier on the right side of the mesh was missing.An exhaustive search for the mesh carrier was performed within the obturator fascia and within the periosteum of the right descending pubic ramus, but the mesh carrier was not found.Only the right arm of the mesh and the left arm with its mesh carrier were removed.The patient was taken in stable condition to the recovery room with no complications.Diagnosis: mesh left and right, removal: fibrous tissue and skeletal muscle with giant cell reaction to foreign material.The patient also presented for surgical management of pelvic pain.She reports pelvic pain (muscle pulling sensation, foreign body sensation) since undergoing a total vaginal hysterectomy with bso, uterosacral vault suspension, posterior repair, perineorrhaphy, and mid-urethral sling on (b)(6) 2019.She is s/p excision of a mid-urethral sling and is now requesting to have it removed.Additionally, the patient reports consistent feelings of vaginal prolapse.She feels a potential prolapse at the level of the mid vagina upon self-examination and is wondering whether her vaginal prolapse is returning.On physical exam in the clinic, there was noted to be hypertonicity and pain of both left and right obturator and coccygeus.On (b)(6) 2021, the patient did an ultrasound exam due to a possible sling mesh carrier right obturator fascia pubis ramus.In accordance with the surgical note and possible residual mesh fragment, a detailed focused ultrasound of the right lateral pelvic sidewall in the region of the obturator fascia was performed.Linear echogenic mesh is seen in the expected area of the obturator fascia along the far lateral inferior pelvic sidewall.The mesh fragments measure 1.5 cm in length and about 5 mm in thickness.Impression: small 1.5 x 0.5 cm mesh fragments were seen in the right lateral inferior pelvic sidewall in the expected location of obturator fascia as described.No midline mesh or fragments are seen in keeping with the removal of the urethral sling.On the next year, (b)(6) 2022, the patient had an mri exam to check the remnant mesh carrier right obturator muscle.The mri result has been compared to the result of the ultrasound exam the patient had in 2021.Postsurgical changes of hysterectomy are seen.Multiple foci of susceptibility artifacts are seen along the vaginal cuff in keeping with postsurgical change.A small focus of susceptibility artifact is seen inferiorly adjacent to the right puborectalis musculature and lateral to the right vaginal cuff.Findings may correspond to the remnant mesh material seen on a recent ultrasound.Findings of pelvic floor descent with ballooning of the puborectalis musculature.Findings: 1.Pelvic small bowel loops appear within normal limits.Visualized aspects of the rectum and colon without evidence of acute inflammation.2.Partial visualization of an exophytic lesion arising from the inferior aspect of the left kidney, which demonstrates intrinsic t1 signal and no appreciable enhancement suggestive of a partially imaged hemorrhagic renal cyst.3.Gallbladder appears filled with gallstones.Impression: 1.Small focus of susceptibility artifact is seen along the right puborectalis musculature lateral to the vaginal cuff is thought to correspond to the remnant 2.Mesh material seen on prior ultrasound.3.Findings of pelvic floor descent with ballooning of the puborectalis musculature.4.Partially imaged probable left-sided hemorrhagic renal cyst.5.Gallbladder is only partially visualized but appears filled with gallstones.

• 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: 15744880
• MDR Text Key: 303174279
• Report Number: 3005099803-2022-06525
• 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,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2023
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Female