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

Model Number M0068503001

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Arrhythmia (1721); Pain (1994); Scar Tissue (2060); Dyspareunia (4505)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The excised mesh 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 lynx suprapubic sling system was implanted into the patient during a mid-urethral sling placement procedure performed on (b)(6) 2014 to treat female stress urinary incontinence.On (b)(6) 2019, the patient was seen for mesh related pain.On exam, there was no mesh exposure noted but the patient had an extreme pelvic pain.The patient mentioned that she was experiencing pain since she had the mid-urethral sling surgery and had dyspareunia.Also, she was very emotional and upset about the whole experience.However, the patient stated that the sling was working and she did not have any leakage.After thorough discussion of all the patient's options to manage her pelvic pain, including conservative measures, the patient wanted to undergo a surgical excision of her prior mesh.The physician discussed the risks and benefits with the patient.All of the patient's questions were answered to her satisfaction, expressed understanding, and agreed with the surgical plan.On (b)(6) 2019, the patient underwent an exam under anesthesia, revision/excision of prior retropubic mid-urethral sling, excision of scar tissue, and cystourethroscopy procedure to treat her pelvic pain subsequent to placement of mid-urethral sling.During the procedure, a 2 cm incision was made in the mid-urethra using a scalpel where the prior retropubic sling was placed.During this dissection, something hard could be palpated distally that felt like the prior mesh.Using meticulous dissection with metzenbaum scissors, a portion of the mesh was identified and was grabbed with a hemostat.The mesh was found to be bunched up and no good plane could be identified to remove the mesh in one piece.So, the mesh was excised in the middle.One edge was grabbed with the hemostat on the right side and the epithelium around it was undermined.The mesh was also gently separated from the periurethral tissue.The mesh was then grabbed at its most distal portion and trimmed as close to the pubic bone as possible.Similar steps were repeated in the opposite side.At the end of the procedure, there were no obvious mesh palpated and the scarring that was palpated preoperatively was not palpated anymore.Subsequently, an extensive irrigation was performed, and hemostasis confirmed.The vaginal epithelium was closed using a 2.0 vicryl, and then the epithelial edges were approximated using a running stitch.Moreover, hemostasis was noted afterwards.Reportedly, there were no immediate complications at the time of surgery, and post-operatively, the patient did well.In addition, the physician discussed cardiac arrhythmia at bedside with the patient and her husband, and the patient was advised to follow-up with her cardiologist.

• 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): 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: 12364335
• MDR Text Key: 268021282
• Report Number: 3005099803-2021-04309
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718956
• UDI-Public: 08714729718956
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2021

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: 11/30/2016
• Device Model Number: M0068503001
• Device Catalogue Number: 8503001
• Device Lot Number: ML00001913
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 77