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 Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Calcium Deposits/Calcification (1758); Incontinence (1928); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Anxiety (2328); Depression (2361); Obstruction/Occlusion (2422); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Insufficient Information (4580)

Event Date 10/24/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a single solyx sis system was implanted on (b)(6) 2018 during a total vaginal hysterectomy with anterior repair, uterosacral colpopexy, posterior repair and tension-free vaginal tape (tvt) procedure for treatment of pelvic pain, prolapse, and stress urinary incontinence.On (b)(6) 2022, the patient had a laparascopic removal of eroded mesh into the bladder.Before the procedure, the patient received intravenous antibiotics.During the procedure, it was noted that the eroded mesh was visualized on the patient's right-hand side at approximately 3 o'clock position away from the bladder neck.A stone was visualized on the mesh and was removed.No other mesh erosion was noted.The area of eroded mesh was removed.The surgical sites were closed in 2 layers.A drain and foley catheter were left in place, with the plan to remove the drain the following morning and the foley to be removed in 2 weeks following cystogram.

Manufacturer Narrative

This event was reported by the patient's legal representation.(b)(6).(b)(4).The complaint device 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

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2022-03673 for the first solyx sis system, and 3005099803-2023-00661 for the second uphold (tm) lite w/ capio slim.It was reported to boston scientific corporation that a single solyx sis system was implanted on (b)(6) 2018 during a total vaginal hysterectomy with anterior repair, uterosacral colpopexy, posterior repair and tension-free vaginal tape (tvt) procedure for treatment of pelvic pain, prolapse, and stress urinary incontinence.On (b)(6) 2022, the patient had a laparascopic removal of eroded mesh into the bladder.Before the procedure, the patient received intravenous antibiotics.During the procedure, it was noted that the eroded mesh was visualized on the patient's right-hand side at approximately 3 o'clock position away from the bladder neck.A stone was visualized on the mesh and was removed.No other mesh erosion was noted.The area of eroded mesh was removed.The surgical sites were closed in 2 layers.A drain and foley catheter were left in place, with the plan to remove the drain the following morning and the foley to be removed in 2 weeks following cystogram.Additional information received on january 20, 2023: as a direct and proximate cause of having the solyx and uphold devices implanted in the patient, she has experienced significant mental and physical pain and suffering, including erosion into the bladder, dyspareunia, neuromuscular pain, pelvic pain, abdominal pain, groin pain, recurrence of incontinence, urinary problems, and vaginal scarring.The patient has undergone medical treatment and will likely undergo further medical treatment and procedures.She has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, and/or lost income, and other damages.In addition to these, the patient reportedly experienced vaginal pain, depression, impaired bladder function, disability and impaired bowel function.

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6), md.Block h6: patient code e2006 captures the reportable event of eroded mesh into the bladder.Patient code e2328 captures the reportable event of stone visualized on the mesh.Impact code f1905 captured the reportable event of removal of eroded mesh.Impact code f2303 captures the reportable event of intravenous antibiotics administration.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).Block h6: patient code e2006 captures the reportable event of eroded mesh into the bladder.Patient code e2328 captures the reportable event of stone visualized on the mesh.Patient code e0206 captures the reportable event of significant mental and physical pain and suffering.Patient code e1405 captures the reportable event of dyspareunia.Patient code e2330 captures the reportable events of neuromuscular pain, pelvic pain, and groin pain, and vaginal pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e2324 captures the reportable event of recurrence of incontinence.Patient code e1311 captures the reportable events of urinary problems and impaired bladder function.Patient code e1715 captures the reportable event of vaginal scarring.Patient code e020202 captures the reportable event of depression.Patient code e2401 captures the reportable event of impaired bowel function.Impact code f1905 captured the reportable event of removal of eroded mesh.Impact code f2303 captures the reportable event of intravenous antibiotics administration.Impact code f1202 captures the reportable event of disability.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

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2022-03673 for the first solyx sis system, and 3005099803-2023-00661 for the second uphold (tm) lite w/ capio slim.It was reported to boston scientific corporation that a single solyx sis system and uphold lte were implanted on (b)(6) 2018 during a total vaginal hysterectomy with anterior repair, uterosacral colpopexy, posterior repair and tension-free vaginal tape (tvt) procedure for treatment of pelvic pain, prolapse, and stress urinary incontinence.On (b)(6) 2022, the patient had a laparoscopic removal of eroded mesh into the bladder.Before the procedure, the patient received intravenous antibiotics.During the procedure, it was noted that the eroded mesh was visualized on the patient's right-hand side at approximately 3 o'clock position away from the bladder neck.A stone was visualized on the mesh and was removed.No other mesh erosion was noted.The area of eroded mesh was removed.The surgical sites were closed in 2 layers.A drain and foley catheter were left in place, with the plan to remove the drain the following morning and the foley to be removed in 2 weeks following cystogram.Additional information received on january 20, 2023: as a direct and proximate cause of having the solyx and uphold devices implanted in the patient, she has experienced significant mental and physical pain and suffering, including erosion into the bladder, dyspareunia, neuromuscular pain, pelvic pain, abdominal pain, groin pain, recurrence of incontinence, urinary problems, and vaginal scarring.The patient has undergone medical treatment and will likely undergo further medical treatment and procedures.She has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, and/or lost income, and other damages.In addition to these, the patient reportedly experienced vaginal pain, depression, impaired bladder function, disability and impaired bowel function.Additional information received on august 9, 2023: on (b)(6) 2021, the patient sought consultation for mesh erosion into her bladder.It was observed that there was a 3mm renal calculi on the left lower pole.The cystoscopy revealed that the mesh erosion on the right side near the bladder neck was the likely source of the bladder stone.Robotic removal of the mesh was discussed during the visit.On (b)(6) 2021, the patient visited for a cystoscopy of kidney stones and bladder mesh, and chronic pelvic pain.The patient was reportedly doing well after the solyx implantation procedure in 2018; however, some time in 2021, she reported having pelvic pain, recurring symptomatic urinary tract infections (uti) and persistent bacteriuria despite the several courses of antibiotics.A cystoscopy performed during the visit revealed an exposed arm of a sling on the anterior bladder wall with calcification.Relevant past medical history noted during the visit: depressive disorder , hashimoto's thyroiditis, generalized anxiety disorder.During the examination of the anterior vaginal wall, a palpable midurethral sling was noted without any visible portion of the mesh exposed in the vaginal space.Findings: at the anterior abdominal wall there was a calcified lesion approximately 1 cm which appeared to be a retention arm of a sling that is encased and calcified encrustation.Assessments: 1.Exposure of implanted vaginal mesh, initial encounter.2.Recurrent uti.On (b)(6) 2022, the patient had a robotic assisted removal of vaginal mesh erosion.She was planned to discharge the following day, but she had bradycardia and light headedness.

Manufacturer Narrative

Blocks b3, b5, b7, d6b, and h6: patient codes have been updated based on the additional information received on august 9, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The mesh removal surgeon is: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of eroded mesh into the bladder.Imdrf patient code e2328 captures the reportable event of stone visualized on the mesh.Imdrf patient code e0206 captures the reportable event of significant mental and physical pain and suffering.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e2330 captures the reportable events of neuromuscular pain, pelvic pain, and groin pain, and vaginal pain.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e2324 captures the reportable event of recurrence of incontinence.Imdrf patient code e1311 captures the reportable events of urinary problems and impaired bladder function.Imdrf patient code e1715 captures the reportable event of vaginal scarring.Imdrf patient code e020202 captures the reportable event of depression.Imdrf patient code e2401 captures the reportable event of impaired bowel function.Imdrf impact code f1905 captures the reportable event of removal of eroded mesh.Imdrf impact code f2303 captures the reportable event of intravenous antibiotics administration.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf patient code e1901 captures the reportable event of pseudomonas aeruginosa infection.Imdrf patient code e230901 captures the reportable event of calcified encrustation.Imdrf impact code f1202 captures the reportable event of disability.Imdrf 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: 15007581
• MDR Text Key: 295860978
• Report Number: 3005099803-2022-03673
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0022108635
• 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
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female