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

Model Number M0068503000

Device Problem Defective Device (2588)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Prolapse (2475); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 04/09/2010

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.Implant surgeons: (b)(6).Explant surgeon: (b)(6).Block h6: imdrf patient codes e2006, e1405, e2015, e230901 and e2333 capture the reportable events of mesh exposure; severe dyspareunia, calcification at midline with significant tissue destruction; recurrent anterior apical prolapse which required surgical intervention.Imdrf impact code f1905 captures the reportable event of excision of mid-urethral exposed mesh.

Event Description

*note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system and lynx system device were implanted into the patient during a bladder neck suspension with midurethral sling + anterior colporrhaphy + extraperitoneal approach with insertion of uphold mesh procedure performed on (b)(6) 2010 for the treatment of stress urinary incontinence and cystocele.The patient appeared to tolerate the procedure well and left the operating room in satisfactory condition.After the procedure, the patient had suffered severe dyspareunia, exposure of vaginal mesh and uterovaginal prolapse.On (b)(6) 2016, she underwent revision surgery for the removal of both the implanted devices.All mesh from the uphold kit was removed safely.Findings: large vaginal exposure of mid-urethral sling with calcification at midline with significant tissue destruction secondary to mesh exposure.Severe bunching and distortion of the mid urethral mesh with tracking pretty distally on the urethra, not noted at the mid urethra.Notably horrible bunching of the uphold mesh, which was safely removed, there was no flattening of the mesh that would suggest support of the anterior vaginal wall.All mesh from the uphold kit removed safely.No evidence of bladder injury upon removal or ureteral injury with bilateral efflux of indigo carmine from both right and left ureteral orifices.As a result of extensive excision of both mid-urethral exposed mesh and removal of uphold mesh, the patient left with a very short anterior vaginal wall of approximately 2cm.Clinical indication: despite the device placement, the patient had residual stress urinary incontinence, severe pain with intercourse, and persistent vaginal bulge.During a consultation, vaginal exposure from the mid - urethral mesh as well as recurrent anterior apical prolapse were noted.It was also reported that the patient experienced renal stones.Cystoscopy performed and revealed no bladder or urethral erosions of mesh.The patient had significant cervical motion tenderness.Specimens: mid urethral sling mesh to pathology.Uphold mesh to pathology.

• 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: 16893738
• MDR Text Key: 314809040
• Report Number: 3005099803-2023-02368
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0ML9111603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female