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

Model Number M0068503000

Device Problems Difficult or Delayed Positioning (1157); Material Twisted/Bent (2981)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Pain (1994); Perforation (2001); Scar Tissue (2060); Discomfort (2330); Prolapse (2475); Dyspareunia (4505)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the mesh implant date.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 mid-urethral sling system was implanted into the patient during a laparoscopic assisted vaginal hysterectomy (lavh), bilateral salpingectomy and removal of essure devices, culdoplasty, tension-free vaginal tape, cystoscopy, posterior repair, and perineorrhaphy procedure performed on (b)(6) 2016 to treat menorrhagia, dysmenorrhea, pelvic pain, stress incontinence, and posterior vaginal prolapse.During the tvt procedure, after both needles were in place, and cystoscopy was performed, a perforation was initially noted with the right needle.Subsequently, the needle was removed, and the foley was replaced.Then, the needle was placed through the abdominal incision, hugging the pubic bone slightly more lateral.Cystoscopy was then repeated and there was no evidence of bleeding or perforation of the bladder was seen anymore.Moreover, needles were not seen in the bladder.The patient was administered with fluorescein, and jets of neon urine were seen from each ureter.Foley was then replaced.The loops were then engaged on the needles affixing the sling device to the needles.The needles were then pulled up through the abdominal incision taking care that the mesh assembly was flat under the mid-urethra.The mesh assembly was then tightened under the mid-urethra with mayo scissors behind the mesh to adjust tension.The blue centering tab was cut, and the plastic sheathing was then removed leaving the mesh in place.The mesh was noted to be flat over the mid-urethra with appropriate tension and was then trimmed at the abdominal exit points.Vaginal incision was closed with 2-0 vicryl in running locking fashion.After the procedure, the findings revealed enlarged uterus, and the essure devices appeared to be in correct position in fallopian tubes.Reportedly, the patient was in stable condition.On (b)(6) 2020, the patient underwent transvaginal removal of mid-urethral sling, posterior repair, perineorrhaphy and cystoscopy procedure to treat urethral mesh exposure, dyspareunia, pelvic pain, and rectocele.The patient experienced mesh exposure, and her main bothersome symptoms were vaginal pain along with a "sawing" and tugging vaginal sensation which occurred during normal activities.She had extreme discomfort with intercourse and exam.This pain was reproducible with palpation of the exposed vaginal mesh.She experienced a few isolated episodes of suprapubic/lower abdominal discomfort.A transvaginal ultrasound (tvus) procedure was done to the patient which revealed normal ovaries and no free fluid.She had previously attempted several months of vaginal estrogen therapy and pelvic floor physical therapy without improvement.Moreover, she strongly desired excision of mesh.Preoperative urodynamics were performed that showed urgency, complete emptying, no detrusor overactivity, and no stress incontinence.Additionally, she had been bothered by pelvic organ prolapse symptoms and the sensation that "everything is going to fall out." physical exam revealed distal rectocele and widened genital hiatus.Options for treatment were reviewed and included expectant management, pessary, physical therapy, and surgery.Stll, the patient strongly desires concomitant surgical correction.Examination under anesthesia was performed to the patient and revealed 1.5cm x 3mm area of exposed mid-urethral sling mesh noted on the right anterior vaginal sulcus.There was no abnormal discharge, and no surrounding erythema.While the left arm of sling was not exposed in vagina, and widened genital hiatus (5.5cm).Moreover, the rectovaginal exam revealed distal rectocele.There was scar tissue from prior procedures on anterior vaginal wall, although soft and pliable, it was redundant.Furthermore, the left arm of the mesh appeared twisted and more distal than anticipated.The cystoscopy procedure revealed no urethral or bladder injuries noted after completion of mesh excision, and normally positioned ureteral orifices.There were no tumor, stone, mesh, or other foreign body.The urothelium appeared hyperemic and inflamed possibly related to cystitis.Also, the urethra was patulous.Reportedly, at the conclusion of the procedures, the patient had no rectal injury and had good rectovaginal support.

• 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: 12373011
• MDR Text Key: 268319659
• Report Number: 3005099803-2021-04292
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2021

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: 05/09/2019
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0000030472
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 93