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

Model Number M0068507000

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Insufficient Information (4580)

Event Date 02/25/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2020.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2021.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh removal surgery.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 reported healthcare facility is: (b)(6).(b)(4).The complaint device 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

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2020.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6), 2021.Boston scientific corporation received additional information on january 12, 2022 as follows: on (b)(6), 2020, the patient underwent a robot assisted laparoscopic hysterectomy, bilateral salpingectomy, culdoplasty, bilateral uterosacral ligament colpopexy, anterior and posterior colporrhaphy, enterocele repair perineorrhaphy, mid-urethral sling and cystourethroscopy procedure for the treatment of mixed stress and urge urinary incontinence.After the procedure, the patient had a mesh exposure at the right vaginal sulci.Subsequently, the patient underwent a mesh removal and cystoscopy procedure on (b)(6), 2021.During the surgery, it was found that the mesh appeared to be tracking from 2 o' clock at the mid-urethra to the 8 o' clock position in the right vaginal sulci - rather than being 3-9 o' clock position on the urethra.Cystoscopy was then repeated at the end of procedure and there was no bladder or urethral injury noted.There was no mesh erosion in the bladder or urethra.Bilateral ureteral efflux was noted.The patient was taken to the recovery room in a stable condition.She tolerated the procedure well.

Manufacturer Narrative

Block h2: blocks a2, a3, b5 and h6 have been updated based on additional information received on january 13, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh removal surgery.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the implant surgeon is: (b)(4).The mesh removal surgeon is: (b)(4).Block h6: patient code e2006 captures the reportable event of vaginal mesh exposure.Impact code f1903 captures the reportable event of mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device 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.

• 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: 13119302
• MDR Text Key: 282978104
• Report Number: 3005099803-2021-07930
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

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 Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 02/10/2022
• 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: 52 YR
• Patient Sex: Female