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

Model Number M0068507000

Device Problem Positioning Problem (3009)

Patient Problems Prolapse (2475); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021 the date the patient had revision surgery, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Surgeon for revision surgery: dr.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem 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 vaginal hysterectomy + right salpingectomy + anterior repair + bilateral sacrospinous ligament suspension + solyx placement + cystoscopy performed on (b)(6) 2018 for pelvic organ prolapse causing vaginal bulge and sui.After implant procedure, the patient developed sacral decubitus ulcer, severe voiding dysfunction and recurrent pelvic organ prolapse symptoms in the form of a large grade 3 cystocele, enterocele, and cuff prolapse.Subsequently, on (b)(6) 2021, the patient had to undergo surgery for anterior colporrhaphy, removal of sling, vaginal enterocele repair, sacral ligament plication and bilateral sacrospinous ligament fixation.The sling was noted to be deep to the periurethral fascia and was very tight on the mid-urethra making dissection off the urethra difficult; however, this was accomplished without injuring the urethra.The patient tolerated the procedure well, was returned to recovery room in good 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15329522
• MDR Text Key: 299002684
• Report Number: 3005099803-2022-04912
• 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: 08/31/2022

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: 03/04/2021
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0021816285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female