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 Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Insufficient Information (4580)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the mesh removal surgery.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).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.

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) 2016.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2018.

Manufacturer Narrative

Block h2: blocks a2, a3, b5 and h6 have been updated based on additional information received on february 15, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The surgeon is: (b)(6) dr.(b)(6).Block h6: patient code e2330 and e2006 captures the reportable event of pain and extrusion.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.

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) 2016.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2018.Boston scientific corporation received additional information on february 15, 2022, as follows: years after the mesh was implanted, the patient had presented with mesh exposure.The patient also stated that she is experiencing pain and bleeding due to the implanted mesh.Subsequently, the patient underwent a mini-arch suburethral sling removal and cystoscopy on (b)(6) 2018.Her preoperative diagnoses were suburethral sling extrusion and vulvodynia.Almost complete extrusion of mesh material was noted.During the procedure, dissection was performed to approximately 3 cm laterally on both sides.The tips of the mini-arc sling were encountered and the complete sling was removed without complications.Cystoscopy was performed; no urethral defects were noted and the bladder mucosa was noted to be smooth and intact.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable 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): 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: 12697262
• MDR Text Key: 278352336
• Report Number: 3005099803-2021-05368
• 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: 03/15/2022

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: 09/01/2018
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00003169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female