MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507010

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

Patient Problems Wound Dehiscence (1154); Erosion (1750)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6), 2021, implant procedure date, as no event date was reported.This event was reported by the patient's legal representation.The implanting and explanting surgeon is: (b)(6) (b)(4).The complainant indicated that the device is not available for return; therefore, a device 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 device was implanted into the patient during a total vaginal hysterectomy, bilateral salpingi-oopherectomy, mid-urethral sling procedure, cystoscopy, labiaplasty, posterior colporrhaphy, enterocele repair, moschcowitz procedure, sacrospinous ligament suspension, perineorrhaphy procedure performed on (b)(6), 2021 for the treatment of prolapse, incontinence, labial hypertrophy, cystocele, rectocele, enterocele, perineal floor weakness, uterine prolapse.On (b)(6) 2022, the patient underwent a resection of exposed vaginal mesh, re-approximation of vaginal mucosa, and cystoscopy due to vaginal mesh exposure secondary to non-healing of wound.There was evidence of wound dehiscence in the right vaginal apical wall with 1 cm of exposed vaginal mesh.The patient was brought into the operating room and placed supine on the operating table.General anesthesia via oral endotracheal tube was performed.The patient was placed in the trendelenburg position.She was prepped and draped in the usual fashion for vaginal surgery.A catheter for urine was obtained for culture.A 0.5% marcaine with epinephrine was instilled into the vaginal mucosa in the area of mesh exposure.An allis clamp was applied to the mesh for gentle traction.Using metzenbaum scissors, the mesh was excised.

• 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: 15499583
• MDR Text Key: 300731374
• Report Number: 3005099803-2022-05542
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• 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: 09/27/2022

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: 07/14/2024
• Device Model Number: M0068507010
• Device Lot Number: 0027674722
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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
• Patient Age: 41 YR
• Patient Sex: Female