MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068503000

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

Patient Problems Erosion (1750); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Discomfort (2330)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.Implant surgeon: dr.(b)(6).Explant surgeon: dr.(b)(6).(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during an examination under anesthesia + tension free suburethral retropubic sling with mesh + cystoscopy procedure performed on (b)(6) 2021 to treat stress urinary incontinence.During the implant procedure, initial placement of right needle pierced the bladder, but it was not bleeding.There was no distortion or violation of the bladder by the needles confirmed prior to pulling the sling into position.Sulci were checked and were not violated.Patient was taken to pacu in satisfactory condition.Patient reported feeling ready, comfortable and safe for discharge.On (b)(6) 2022, exposure of vaginal mesh was noted.Patient was taking oxycodone roxicodone for severe pain and valacyclovir valtrex.On (b)(6) 2022 patient underwent mesh removal surgery due to mesh exposure.It was reported that mesh was palpable in vagina.It was grasped with allis clamp.Dissected with metz scissors then grasped and dissected under mesh.Mesh was divided in midline.Both pieces of mesh were cut at pubic ramus.No stones, tumors, foreign body, mesh, or other abnormality observed in the urethra or the bladder.Final diagnosis on specimen submitted were that portions of fibrous tissue embedded with the mesh and surrounding chronic inflammation.

Manufacturer Narrative

Blocks b5, b7 and h6 patient code have been updated based on the additional information received on june 8, 2023.Block e1: this event was reported by the patient's legal representation.Implant surgeon: dr.(b)(6).Explant surgeon: dr.(b)(6).Uconn health, 263 farmington avenue, farmington, ct 06030.Block h6: imdrf patient codes e2006, e211401, e2326, e2330 and e2311 capture the reportable events of vaginal mesh exposure, initial placement of right needle pierced the bladder, chronic inflammation, pain and vaginal discomfort.Imdrf impact code f1903 captures the reportable event of mesh removal.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during an examination under anesthesia + tension free suburethral retropubic sling with mesh + cystoscopy procedure performed on (b)(6) 2021 to treat stress urinary incontinence.During the implant procedure, initial placement of right needle pierced the bladder, but it was not bleeding.There was no distortion or violation of the bladder by the needles confirmed prior to pulling the sling into position.Sulci were checked and were not violated.Patient was taken to pacu in satisfactory condition.Patient reported feeling ready, comfortable and safe for discharge.On (b)(6) 2022, patient had an office visit complaining of vaginal discomfort.She was feeling something sharp in the vagina anteriorly and complaining of increased vaginal pressure or discomfort.Patient was concerned this was related to the mirena iud she had inserted in (b)(6) 2021.Iud threads were 6mm beyond the cervical os.However, iud threads were trimmed but could still feel the same sharp area in the vagina.Examination findings included iud was properly placed and not the cause of discomfort.It was also reported that there was small area of mesh erosion palpable to the right of the midline which causes tenderness.Urinalysis, culture and sensitivity, and vaginal/cervical cultures were scheduled to be checked to rule out other etiology of her discomfort especially given recent new partner.Patient had a plan to follow up with surgeon who placed the sling and discussed revision of exposed sling.Assessment/plan: 1.Vaginal discomfort, cystology procedures, urine culture, urinalysis-macroscopic with reflex microscopic.2.Erosion of suburethral sling, initial encounter.3.Iud check up.On (b)(6) 2022, exposure of vaginal mesh was noted.Patient was taking oxycodone roxicodone for severe pain and valacyclovir valtrex.On (b)(6) 2022, patient underwent mesh removal surgery due to mesh exposure.It was reported that mesh was palpable in vagina.It was grasped with allis clamp.Dissected with metz scissors then grasped and dissected under mesh.Mesh was divided in midline.Both pieces of mesh were cut at pubic ramus.No stones, tumors, foreign body, mesh, or other abnormality observed in the urethra or the bladder.Final diagnosis on specimen submitted were that portions of fibrous tissue embedded with the mesh and surrounding chronic inflammation.

• Brand Name: LYNX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 16443387
• MDR Text Key: 310246673
• Report Number: 3005099803-2023-00904
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

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: 08/04/2023
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0025808011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic