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

Model Number M0068507001

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

Patient Problem Insufficient Information (4580)

Event Date 07/29/2011

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2011, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for an unspecified personal injury related to the device.

Event Description

Note: this report pertains to the second of two solyx sis system devices used during the same procedure.Please refer to mfr report 3005099803-2023-03550 for associated device.It was reported to boston scientific corporation that two solyx sis system devices were used during the anterior and posterior repair, solyx sling placement, and a cystoscopy procedure performed on (b)(6) 2011, for the treatment of cystocele, rectocele, and stress urinary incontinence.During the procedure, they first performed dissection for anterior repair and the solyx sling.The first solyx sling was implanted, the anterior repair was performed, and incisions closed.Cystoscopy was performed with normal findings.Then the retractor was placed in preparation for the posterior repair.At this time, they noticed the first solyx sling protruding from the mucosa on the right side.So, they opened the vaginal incision about one inch on top, dissected the sling at the midline and it was removed with the clamps.The second solyx sling was then placed under digital control, first on the patient's right and subsequently on the left.The mucosa was closed, and a second cystoscopy was performed with no findings.The patient then underwent posterior repair with no complications.The patient tolerated the procedure well and was brought to the recovery room in stable condition.As reported by the patient's attorney, the patient experienced an unknown injury.

• 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: 17222554
• MDR Text Key: 318072371
• Report Number: 3005099803-2023-03262
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: 1ML1012002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female