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 Abdominal Pain (1685); Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Urinary Frequency (2275); Injury (2348); Disability (2371); Prolapse (2475); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.This event was reported by the patient's legal representation.Additional attorney: (b)(6).Surgeon: (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 sling device was implanted into the patient on (b)(6) 2016.As per reported by the patient's attorney, after the implantation, the patient has suffered dyspareunia, severe pain, further urinary problems, and infections.The patient also claims to have suffered mental anguish, physical impairment, and medical care expenses.Boston scientific has been unable to obtain additional information regarding the event and the patient's condition to date.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2018 (first clinic visit post implantation), as no event date was reported.Block e1: this event was reported by the patient's legal representation.Additional attorney: (b)(6).Surgeon: (b)(6).Block h6: patient codes e2401, e1405, e1906, e2330, e2326, e2006 and f1903 capture the reportable events of physical impairment, severe pain, further urinary problems, and infections, inflammation, extrusion, and mesh removal procedure.Block h10: the removed mesh 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 sling device was implanted into the patient on (b)(6) 2016.As per reported by the patient's attorney, after the implantation, the patient has suffered dyspareunia, severe pain, further urinary problems, and infections.The patient also claims to have suffered mental anguish, physical impairment, and medical care expenses.Boston scientific has been unable to obtain additional information regarding the event and the patient's condition to date.Additional information received on 14jan2022: medical and surgical history included 3 vaginal deliveries.It was reported that the patient had been diagnosed with stress incontinence with cystocele grade 2, rectocele grade 3.On (b)(6) 2016, she underwent a vaginal sling placement procedure with cystoscopy and cystocele repair using kelly plication technique.The patient declined rectocele repair as she was asymptomatic.On (b)(6) 2018, during a physical therapy evaluation, the patient reported she has had new onset of pelvic pain, pain with insertion, urinary frequency and stress urinary incontinence since the procedure.She stated she had several doctors examine her and says she was told the material used in surgery was dislodged and relocated.Patient also reports abdominal pain and swelling and little balls in her abdomen that cause pain.Exam revealed a gaping introitus; tenderness to palpation at the periurethral tissue, levator ani, obturator internus, endopelvic fascia, and coccygeus right greater than left; mild anterior prolapse.The assessment was pelvic floor muscle weakness and spasm associated with urinary incontinence and pain with insertion.The plan was for physical therapy once weekly for 4 weeks.Patient underwent surgery on (b)(6) 2018, to remove the sling vaginally.Patient had been experiencing persistent pelvic pain with incontinence, mainly urge incontinence.During the procedure, the site of vaginal mesh extrusion was identified at the right lateral anterior vaginal wall.The mesh was dissected laterally on both sides to free the mesh enough to place a right angle clamp underneath it.Residual mesh was successfully removed in its entirety on both sides.Pathology report showed fibrovascular tissue with acute and chronic inflammation.

Manufacturer Narrative

Additional information: blocks a2, b3, b5, d6b, and h6.Block b3 date of event: date of event was approximated to (b)(6), 2018 (first clinic visit post implantation), as no event date was reported.Block e1: this event was reported by the patient's legal representation.Additional attorney: (b)(6).Surgeon: (b)(6).Block h6: patient codes e2401, e1405, e1906, e2330, e2326, e2006 and f1903 capture the reportable events of physical impairment, severe pain, further urinary problems, and infections, inflammation, extrusion, and mesh removal procedure.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 sling device was implanted into the patient on (b)(6) 2016.As per reported by the patient's attorney, after the implantation, the patient has suffered dyspareunia, severe pain, further urinary problems, and infections.The patient also claims to have suffered mental anguish, physical impairment, and medical care expenses.Boston scientific has been unable to obtain additional information regarding the event and the patient's condition to date.Additional information received on 14jan2022.It was reported that the patient had been diagnosed with stress incontinence with cystocele grade 2, rectocele grade 3.On (b)(6), 2016, she underwent a vaginal sling placement procedure with cystoscopy and rectocele repair using kelly plication technique.On (b)(6), 2018 during a clinic visit, patient reports she has had new onset of pelvic pain, pain with insertion, urinary frequency and stress urinary incontinence.She stated she had several doctors examine her and says she was told the material used in surgery was dislodged and relocated.Patient also reports abdominal pain and swelling and "little balls" in her abdomen that case pain.A mild anterior prolapse was also noted during the visit.Patient underwent surgery on (b)(6) 2018 to remove the sling vaginally.Patient had been experiencing persistent pelvic pain with incontinence, mainly urge incontinence.During the procedure, the site of vaginal mesh extrusion was identified and dissected laterally on both sides to free the mesh enough to place a right angle clam underneath it.Residual mesh was successfully removed in its entirety on both sides.Pathology report showed fibrovascular tissue with acute and chronic inflammation.

• 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: 9897999
• MDR Text Key: 189611747
• Report Number: 3005099803-2020-01322
• 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: Non-Healthcare Professional
• 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: 09/01/2018
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00003169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female