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 Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Urinary Incontinence (4572)

Event Date 08/25/2010

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6), (b)(6) hospital.Implant surgeon for xenform device: dr.(b)(6), (b)(6) hospital.Explant surgeon: dr.(b)(6).Imdrf patient codes e2330, e2311 and e1310 capture the reportable events of pain, discomfort and urinary tract infection.Imdrf impact code f1903 captures the reportable event of mesh appeared to be resected in its entirety.

Event Description

Note: this manufacturer report pertains to the third of three devices used during the same procedure.It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a anterior repair with graft + vaginal sacral colpopexy mid urethral solyx sling procedure performed on (b)(6) 2010, for the treatment of stress urinary incontinence, leak point pressure 100cm, grade 2 - 3 cystocele with incomplete vaginal vault prolapse.Findings stated the patient had cystocele with hypermobile urethra.The operation was completed with no complications.The patient was awakened and taken to the recovery room in stable condition.The patient claimed that since the mesh placement, she had problems with recurring urinary tract infections as well as persistent incontinence, pelvic pain and discomfort.On (b)(6) 2015, the patient underwent surgical removal of vaginal mesh with anterior repair and cystoscopy.During the procedure, the mesh was split down the middle and then slowly dissected off both sides, it came off in two pieces and appeared to be resected in its entirety.The patient was awoken and brought to the recovery room in stable condition.

• 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: 16808187
• MDR Text Key: 313935310
• Report Number: 3005099803-2023-02031
• 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
• Report Date: 04/25/2023

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: 04/30/2013
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 1ML0042702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female