MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Calcium Deposits/Calcification (1758); Pain (1994); Scar Tissue (2060); Anxiety (2328); Depression (2361); Obstruction/Occlusion (2422); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 10/24/2021

Event Type  Injury  

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 an uphold lite and solyx sis system device was implanted into the patient during a total vaginal hysterectomy, anterior repair, uterosacral colpopexy, posterior repair and tension-free vaginal tape procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence and pelvic organ prolapse.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.Moreover, 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

The exact event onset date is unknown.The provided event date of august 22, 2018, was chosen as a best estimate based on the date of the mesh was implanted.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).The following imdrf patient code capture the reportable event of: e2006 captures the reportable event of eroded mesh into the bladder.E2328 captures the reportable event of stone visualized on the mesh.E0206 captures the reportable event of significant mental and physical pain and suffering.E1405 captures the reportable event of dyspareunia.E2330 captures the reportable events of neuromuscular pain, pelvic pain, and groin pain, and vaginal pain.E1002 captures the reportable event of abdominal pain.E1311 captures the reportable events of urinary problems and impaired bladder function.E1715 captures the reportable event of vaginal scarring.E020202 captures the reportable event of depression.E2401 captures the reportable event of impaired bowel function.The following imdrf impact code capture the reportable event of: f1905 captured the reportable event of removal of eroded mesh.F2303 captures the reportable event of intravenous antibiotics administration.F1202 captures the reportable event of disability.F12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Manufacturer Narrative

Blocks b3, b5, b7, d6b, and h6: patient codes have been updated based on the additional information received on august 9, 2023.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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: the following imdrf patient code capture the reportable event of: e2006 captures the reportable event of eroded mesh into the bladder.E2328 captures the reportable event of stone visualized on the mesh.E0206 captures the reportable event of significant mental and physical pain and suffering.E1405 captures the reportable event of dyspareunia.E2330 captures the reportable events of neuromuscular pain, pelvic pain, and groin pain, and vaginal pain.E1002 captures the reportable event of abdominal pain.E1311 captures the reportable events of urinary problems and impaired bladder function.E1715 captures the reportable event of vaginal scarring.E020202 captures the reportable event of depression.E2401 captures the reportable event of impaired bowel function.E230901 captures the reportable event of calcified encrustation.The following imdrf impact code capture the reportable event of: f1905 captures the reportable event of removal of eroded mesh.F2303 captures the reportable event of intravenous antibiotics administration.F1202 captures the reportable event of disability.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 an uphold lite and solyx sis system device was implanted into the patient during a total vaginal hysterectomy, anterior repair, uterosacral colpopexy, posterior repair and tension-free vaginal tape procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence and pelvic organ prolapse.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.Moreover, 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.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.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• 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: 16370895
• MDR Text Key: 309468811
• Report Number: 3005099803-2023-00661
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 62 YR
• Patient Sex: Female