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

Model Number M0068507001

Device Problem Defective Device (2588)

Patient Problem Prolapse (2475)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6), 2021, date of first surgical procedure post implant, as no event date was reported.This event was reported by the patient's legal representation.Sling placement (b)(6) 2013): dr.(b)(6).Cystocele/rectocele repair (b)(6) 2021): dr.(b)(6).Robotic sacrocolpexy and cystoscopy (b)(6) 2022): dr.(b)(6).

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted during a da vinci robotic laparoscopy lysis of abdominal adhesions, da vinci robotic laparoscopic sacrocolpopexy with y-mesh (non-bsc), solyx suburethral sling placement cystoscopy procedure performed on (b)(6), 2013 for the treatment of abdominal adhesions, vaginal vault prolapse status post hysterectomy, stress urinary incontinence and ovarian cyst adenoma.On (b)(6), 2021, the patient underwent cystocele and rectocele repair.During the procedure, both anterior and posterior prolapse were seen with examination under anesthesia and repairs were done for both.The tissues were not very strong, especially posteriorly.The patient tolerated the procedure well without complications.Reportedly, the patient experienced recurrent pelvic organ prolapse after the robotic sacrocolpopexy and midurethral sling placement in 2013, as well as the transvaginal anterior and posterior colporrhaphy in (b)(6) 2021 that subsequently failed.On (b)(6), 2022, she underwent robotic sacrocolpopexy and cystoscopy to treat the recurrent cystocele and rectocele.During the procedure, the patient's prior mesh was identified which appeared very loose and looked like it had moved out of position as it only appeared at the very apex of the vaginal vault.The mesh was dissected starting just beneath the level of the right iliac artery.The right ureter was identified and a dissection was carried our to the apex of the vaginal vault and the mesh was dissected from the vagina.The mesh was dissected proximally to its attachment at the sacral promontory, and was then completely excised.A new non-bsc y-mesh was implanted.Cystoscopy was then performed.No bladder injury or mesh was seen.The bladder was examined from the intraperitoneal side and no leaks were seen.Urethra appeared normal and no incontinence was noted from the urethral meatus.The procedure was completed without complications.

• 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: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15527031
• MDR Text Key: 301011020
• Report Number: 3005099803-2022-05459
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• 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: 10/03/2022

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: 08/31/2015
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: ML00000908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2012
• 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: 60 YR
• Patient Sex: Female