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

Model Number M0068507000

Device Problem Malposition of Device (2616)

Patient Problems Erosion (1750); Micturition Urgency (1871); Headache (1880); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Vomiting (2144); Anxiety (2328); Depression (2361); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision surgery physicians are: (b)(6).(b)(4).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

Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system and solyx sis system devices were implanted into the patient during a sacral spinous ligament fixation + vault suspension + uphold mesh graft for repair + solyx for hypermobility of the urethra procedure performed on (b)(6) 2014 for the treatment of grade lll anterior vaginal wall prolapse with grade ll uterine prolapse.On (b)(6) 2019, the symptoms of dyspareunia, mixed stress and urge urinary incontinence, myofascial muscle pain and pelvic pain were noted.The patient also experienced problems like anxiety, chronic back pain, chronic constipation, depression, fibromyalgia, hyperlipidemia, migraine, postoperative nausea and vomiting.On (b)(6) 2019, the patient underwent vaginal urethrolysis, mesh removal, 50 units botox injection and kelly plication and anterior colporrhaphy.During mesh removal, a scarring underneath the urethra and inflammation around mesh were noted.It was also found that the sling was too close to the bladder neck and on the left side of the patient, there was dense scar and looks like the sling was partially through the periurethral tissue.Body tissue grew into the mesh, so it was generally impossible to remove all of the mesh that was placed during the original sling procedure.Patient awoken from anesthesia and transferred stable to postoperative recovery room.No 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12372333
• MDR Text Key: 268295876
• Report Number: 3005099803-2021-04271
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 67