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); Erosion (1750); Dehydration (1807); Micturition Urgency (1871); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Chills (2191); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Hematuria (2558); Dysuria (2684); Constipation (3274); Unspecified Kidney or Urinary Problem (4503); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure 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 sis system was implanted during a procedure performed on (b)(6) 2013.As reported by the patient's attorney, the patient has experienced an unknown injury.Reportedly, on (b)(6) 2018, a non-bsc sling was also implanted to the patient.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted during a procedure performed on (b)(6) 2013.As reported by the patient's attorney, the patient has experienced an unknown injury.Reportedly, on (b)(6) 2018, a non-bsc sling was also implanted to the patient.Additional information received on january 14, 2022 patient had been diagnosed with stress urinary incontinence.On (b)(6) 2013, patient underwent transvaginal bladder sling implantation.On (b)(6) 2017, patient sought urologic consultation for evaluation and management of recurrent urinary tract infections, stating that for the past two years she has had infections two times per month.She reports that when she has a uti, she has symptoms of nausea, vomiting, odor, straining and urgency.She admits to sui and wears 10 pads per day and states that these are saturated.Visit diagnoses: pyuria, midline cystocele, nausea, sui.She went again for a follow up on (b)(6) 2017 for the same complaints.This time she was also diagnosed with mixed incontinence urge and stress, and a hypocontractile bladder.On (b)(6), 2018 patient underwent flexible cystoscopy due to recurrent utis and incontinence.Findings: exposed mesh in proximal urethra/bladder neck on the left.Patient underwent laser excision of mesh and removal of portion of sling erosion in the urethra on (b)(6) 2018.A month later, she returns for a follow-up stating that she is somewhat improved, doing well and feeling well, satisfied with outcome of her surgery.No new medical problems reported.A follow-up flexible cystoscopy was performed on july 9, 2018 which visualized edge of mesh at approximately 5 to 6 o-clock position.Remaining exposure is where the sling was excised with laser.On (b)(6) 2018, patient returns for follow up after she failed two voiding trials and she has been on cic 4 times a day.She does have an urgency to void and has to get to the bathroom in time with urge to catheterize herself.She is not able to void currently.Additional information received on february 2, 2022 during the laser excision of mesh performed on (b)(6) 2018, the mesh was excised with laser posteriorly and then it was noted that the anchor was protruding through lateral urethra on the left.This was grasped and removed and no further mesh was noted in the urethra.Foley catheter was placed at this time.Four days later, patient presents to emergency department for evaluation of nausea, vomiting, chills and inability to urinate.She also reports right and left lower quadrant pain.On (b)(6) 2018, patient underwent mesh removal procedure.Mesh was excised.Urethral repair performed.Anterior colporrhaphy performed and cadaveric fascia lata sling was placed.Cystoscopy was done with no evidence of bladder injury.No further mesh exposure noted.Over the 24-hr post op period, patient had difficulty achieving adequate pain control overnight, continues to report a constant severe pain located mainly at the site of her incision and radiating down.She states pain medication does not improve but wears off quickly.Pathology report shows no soft tissue attached to the mesh or within specimen container.On (b)(6) 2018, patient presents with lower pelvic pain and inability to urinate after catheter removal.Foley catheter was reinserted.About a month later, patient presents with nausea, vomiting, right sided and right back pain, chills, self cath at home indicates cloudy foul smelling urine for 9 days and vaginal discharge for 2 weeks.

Manufacturer Narrative

Additional information: blocs a2, a6, b2, b3, b5, b7, e1 (see below), h6.Block b3 date of event: date of event was approximated to (b)(6) 2017 (first clinic visit post implant), as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Mesh removal/revision surgeon: dr.(b)(6) (prisma health) second mesh removal procedure: dr.(b)(6) assisted by dr.(b)(6) (prisma health) block h6: patient codes e1404, e2006, e1309, e2330, e1310, e1002 f1903, f2303 capture the reportable events vaginal discharge, mesh erosion, urinary retention, pain right sided and right back, right and left lower quadrant abdominal pain, urinary tract infections, mesh removal/revision surgeries and medications required.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2017 (first clinic visit post implant), as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.Mesh removal/revision surgeon: dr.(b)(6) (prisma health) second mesh removal procedure: dr.(b)(6) assisted by dr.(b)(6) (prisma health) block h6: patient codes e2006, e1310, e1309, e2330, e1002, e0123, e2326, e1311 capture the reportable events of mesh erosion in the urethra, urinary tract infection, urinary retention, right sided and back pain, right and left lower quadrant abdominal pain, neurogenic bladder, interstitial nephritis, acute kidney injury, and chronic kidney disease stage iii, respectively.Impact codes f1903, f2303, and f08 capture the reportable events of laser excision of mesh and removal of portion of sling erosion, medications, and hospitalization, respectively.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 failure 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 sis system was implanted during a procedure performed on (b)(6) 2013.As reported by the patient's attorney, the patient has experienced an unknown injury.Reportedly, on (b)(6) 2018, a non-bsc sling was also implanted to the patient.Additional information received on january 14, 2022: patient had been diagnosed with stress urinary incontinence.On (b)(6) 2013, patient underwent transvaginal bladder sling implantation.On (b)(6) 2017, patient sought urologic consultation for evaluation and management of recurrent urinary tract infections, stating that for the past two years she has had infections two times per month.She reports that when she has a uti, she has symptoms of nausea, vomiting, odor, straining and urgency.She had uti symptoms on the day of the consultation and her urinalysis was nitrite positive.She admits to sui and wears 10 pads per day and states that these are saturated.The patient reported that the bladder mesh placed previously did not help.She also reported decreased urine volume and difficulty urinating, frequency, and pain/discomfort in the lower abdominal or genital area.At the time of the consultation, her medical and surgical history included tubal ligation, total abdominal hysterectomy, cholecystectomy, current smoking, transverse myelitis with left leg weakness and neuropathic pain (in 2002 or 2005), hemorrhoids, hypertension, herpes zoster, anal fissure, and frequent diarrhea.Exam revealed grade 2-3 cystocele, urine leak upon valsalva, and postvoid residual (pvr) of 20 cc.Visit diagnoses: pyuria, midline cystocele, nausea, sui.Urine culture was submitted, and the patient was started on macrobid.The patient was recommended a pessary for her cystocele, retrograde ureteroscopy and upper tract imaging, and cystoscopy.On (b)(6) 2017, the patient was evaluated for the same complaints and recent urodynamics test results were reviewed.Urine culture was positive for e.Coli in november.The patient also reported fecal incontinence and constipation.Exam revealed cough stress test was positive, there was urethral hypermobility, cystocele, no pelvic floor muscle tenderness, and no exposed mesh or banding.Visit diagnoses included midline cystocele, pyuria, mixed incontinence urges and stress, and a hypocontractile bladder.On (b)(6) 2018, the patient underwent flexible cystoscopy due to recurrent utis and incontinence.Findings: exposed mesh in proximal urethra/bladder neck on the left.Patient underwent laser excision of mesh and removal of portion of sling erosion in the urethra on (b)(6) 2018.On (b)(6) 2018, she returned for a follow-up stating that she is somewhat improved, doing well and feeling well, satisfied with outcome of her surgery.She did report stress incontinence but no uti symptoms and noted it was easier to void since surgery.No new medical problems reported.The patient was advised to return for cystoscopy in 4 weeks to evaluate healing of the urethra.A follow-up flexible cystoscopy was performed on july 9, 2018, which visualized mesh erosion into the urethra described as edge of mesh at approximately 5 to 6 o-clock positions.Remaining exposure is where the sling was excised with laser.On (b)(6) 2018, the patient returned for follow up saying she was doing well.She had failed 2 voiding trials after catheter removal and has been on clean intermittent catheterization (cic) 4x/ daily for the past 2 weeks.She does have urgency to void and is able to get to the bathroom in time to catheterize herself.The patient was tolerating cic and elected to continue that and discuss sling lysis if not voiding at all in 4 weeks.Additional information received on february 2, 2022: during the laser excision of mesh performed on february 15, 2018, the mesh was excised with laser posteriorly and then it was noted that the anchor was protruding through lateral urethra on the left.This was grasped and removed, and no further mesh was noted in the urethra.Foley catheter was placed at this time.On (b)(6) 2018, the patient presented to the emergency department with right and left lower quadrant pain, nausea, vomiting, chills, inability to urinate, and hematuria.Her foley had also fallen out and was supposed to remain in place for 2 weeks.The patient appeared dehydrated, and an iv catheter was placed, and fluids administered.A foley catheter was reinserted.Urinalysis was notable for leukocyte esterase, blood, white blood cells, and bacteria.Urine culture was submitted.Patient was admitted to the hospital for iv fluids, antibiotics, anti-emetics, and pain medication.The patient's symptoms improved, and she was discharged on (b)(6) 2018.On (b)(6) 2018, patient underwent mesh removal procedure.Findings included mesh erosion into urethra at proximal urethra/bladder neck posteriorly.Mesh was excised.Urethral repair performed.Anterior colporrhaphy performed and cadaveric fascia lata sling was placed.Cystoscopy was done with no evidence of bladder injury.No further mesh exposure noted.Over the 24-hr post op period, patient had difficulty achieving adequate pain control overnight, continues to report a constant severe pain located mainly at the site of her incision and radiating down.She states pain medication does improve it but wears off quickly.Pathology report shows no soft tissue attached to the mesh or within specimen container.On (b)(6) 2018, patient presents with lower pelvic pain and inability to urinate after catheter removal.Patient urinated directly after removal but has not been able to push to urinate due to pain in her lower abdomen.The patient had 615 mls of urine on bladder scan and was having overflow incontinence.Foley catheter was reinserted, and the patient felt much better.On (b)(6) 2019, the patient presented to the emergency department with nausea, vomiting, right sided and right back pain, chills.She was still self-catheterizing at home and indicates cloudy foul-smelling urine for 9 days and vaginal discharge for 2 weeks.On (b)(6) 2021, the patient's problem list included the following: neurogenic bladder, acute interstitial nephritis (b)(6) 2020, pyelonephritis (b)(6) 2020, pyelonephritis (b)(6) 2018, acute kidney injury (b)(6) 2017), chronic kidney disease stage iii (may 17, 2017), acute pyelonephritis (b)(6) 2017).

• 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: 11392484
• MDR Text Key: 234006081
• Report Number: 3005099803-2021-00797
• 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: 03/24/2022

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: 02/29/2016
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00001303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 01/14/2022; 02/25/2022
• Supplement Dates FDA Received: 02/11/2022; 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Race: Black Or African American