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

Model Number M0068507000

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

Patient Problems Pain (1994); Injury (2348); Prolapse (2475); No Code Available (3191)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

(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 pinnacle pelvic floor repair kits and solyx sis system were implanted into the patient during a procedure performed on (b)(6) 2011.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.Subsequently, the patient had the two devices removed on (b)(6) 2013.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Block h2: additional information: blocks b3, b5, h6, e1 has been updated based on the additional information received on december 8, 2022.Correction: blocks d6b and g2 has been corrected.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the mesh removal.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).The explanting physician is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2330 - pain.The following imdrf impact codes capture the reportable event of: f1905 - device revision.

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 pinnacle pelvic floor repair kits and solyx sis system were implanted into the patient during a procedure performed on (b)(6) 2011.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.Subsequently, the patient had the two devices removed on (b)(6) 2013.Boston scientific has been unable to obtain additional information regarding the event to date.The device was not returned for analysis.Additional information received on december 8, 2022: it was reported to boston scientific corporation that pinnacle pelvic floor repair kits and solyx sis system were implanted into the patient during an anterior mesh repair with bilateral sacrospinous colpopexy, posterior colpoperineorrhaphy single incision vaginal sub urethral sling with cystoscopy procedure performed on october 10, 2011 for the treatment of stress urinary incontinence, cystocele and rectocele.Following the mesh implantation, the patient experienced vaginal pain and recurrent prolapse.Subsequently, the patient underwent a removal of 5cm long anterior vaginal wall mesh, anterior/posterior repair and cystoscopy on (b)(6) 2016.

• 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: 11166999
• MDR Text Key: 226741209
• Report Number: 3005099803-2021-00069
• Device Sequence Number: 1
• Product Code: PAH
• 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: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00000147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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: 77 YR
• Patient Sex: Female