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); Calcium Deposits/Calcification (1758); Obstruction/Occlusion (2422)

Event Date 12/17/2014

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.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: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).First revision surgeon: dr.(b)(6).Block h6: imdrf patient codes e2006, e2328 and e230901 capture the reportable events of mesh erosion in the urethra, left ureteral calculus with hydronephrosis, and ureteral calcification.Imdrf impact code f1903 captures the reportable event of complete mesh removal.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a placement of lynx urethral sling + cystoscopy procedure performed on (b)(6) 2014, for the treatment of stress urinary incontinence.The patient was awakened from anesthesia and transferred to the recovery area in stable condition.On (b)(6) 2021, the patient had her first revision surgery due to left ureteral calculus with hydronephrosis and postoperatively, left-sided ureteral stone hydronephrosis and exposed urethral mesh with ureteral calcification.At the level of the urethra, appeared to be a large calcification which was initially thought as a bladder stone or the passed ureteral stone wash in the urethra.However, this was quite dense in nature.The large calcification was attempted to be extracted from the urethra but was unsuccessful.It was then fragmented into smaller pieces using a 365-holmium laser fiber and was removed completely.The rigid ureteroscope was advanced into the renal pelvis, and retrograde pyelogram was shot showing very mild hydronephrosis.Upon further examination of this ureteral calcification, it was determined that this was likely the exposed mesh from prior mesh surgery.It did appear that this mesh had become calcified through the urethra and traversed directly to the middle of the urethra.The stent was secured with benzo and steri-stips.The stent will be removed in three days.The patient tolerated the procedure well and was brought to the post-anesthesia care unit in stable condition.On (b)(6) 2021, the patient came for cystoscopy with possible endoscopic removal of mesh and possible operative planning due to mesh erosion into urethra.The mesh was identified on the left lateral wall of the urethra at the very, very distal urethra that it was unable to be grasped.The visualization of the mesh with the scope was also quite difficult.Eventually, it was decided to go with surgical excision of the mesh.On (b)(6) 2021, the patient had her second revision surgery due to vaginal mesh erosion.The mesh was identified to the left of midline and was dissected towards the edge of the urethra and was cut free.The opposite edge of the mesh was also dissected as closed to the urethral mucosa as possible and then cut free until there was no remaining mesh evident through the cystoscope.The patient was awakened and transferred to the recovery having tolerated the procedure well.

• 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: 17538457
• MDR Text Key: 321049947
• Report Number: 3005099803-2023-04255
• 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
• Report Date: 08/14/2023

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 Model Number: M0068503000
• Device Catalogue Number: 850-300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/14/2023
• 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: 46 YR
• Patient Sex: Female