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 Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Urinary Incontinence (4572)

Event Date 05/21/2021

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) 2009.Reportedly, the patient was diagnosed with vaginal mesh sling erosion (exposure in the left distal fornix), stress urinary incontinence, urgency urinary incontinence and vaginal pain and underwent cystourethroscopy with bilateral urethrolysis and excision of mesh sling procedure on (b)(6) 2021.Surgical pathology final report dated (b)(6) 2021 revealed the mesh with adherent fibroconnective tissue showing foreign body-type giant cell response and chronic inflammation.The patient tolerated the procedure well and was transferred to pacu in stable condition.

Manufacturer Narrative

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.This event was reported by the patient's legal representation.Implanting physician: (b)(6).Mesh excision surgeon: (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.

• 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: 12865641
• MDR Text Key: 281192972
• Report Number: 3005099803-2021-05962
• 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: Other
• Type of Report: Initial
• Report Date: 11/23/2021

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: 08/31/2012
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0ML9081301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female