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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Erosion (1750); Fever (1858); Micturition Urgency (1871); Headache (1880); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Frequency (2275); Numbness (2415); Hematuria (2558); Fibrosis (3167); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 06/27/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a procedure performed on (b)(6) 2018.The patient claims the following injuries as a result of the procedure: erosion, exposure, recurrence of abdominal pain, back pain, scarring, and removal surgery.Furthermore, the patient claims to have suffered the following damages as a result of the implantation of the lynx system device: physical pain, mental anguish, physical impairment, and medical care expenses.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of the mesh was implanted.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 implanting physician is: dr.(b)(6) (b)(6)hospital (b)(6); (b)(6); (b)(6); (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - used to capture the reported event of erosion and exposure.E0206 - used to capture the reported event of mental anguish.E1715 - used to capture the reported event of scarring.E2330 - used to capture the reported event of back pain and physical pain.The following imdrf impact codes capture the reportable events of: f1903: device explantation - used to capture the reported event of removal surgery.F12: serious injury/ illness/ impairment - patient had filed a legal claim for injuries related to the device.F1202: disability - used to capture the reported event of physical impairment.

Manufacturer Narrative

Block h2: additional information.Blocks a2 (date of birth), b5 (narrative), b7 (other relevant history), d6b (date of explantation) and h6 (patient codes) has been updated based on the additional information received on july 3, 2023.Correction: block e1 (initial reporter first name, initial reporter last name, initial reporter facility name, initial reporter address 1, initial reporter city, initial reporter state, initial reporter zip/post code, initial reporter phone and initial reporter email) has been corrected.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of the mesh was implanted.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 implanting physician is: dr.(b)(6).The physician who performed the revision surgery is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - used to capture the reported event of erosion and exposure.E0206 - used to capture the reported event of mental anguish.E1715 - used to capture the reported event of scarring.E2330 - used to capture the reported event of back pain and physical pain.The following imdrf impact codes capture the reportable events of: f1903: device explantation - used to capture the reported event of removal surgery.F12: serious injury/ illness/ impairment - patient had filed a legal claim for injuries related to the device.F1202: disability - used to capture the reported event of physical impairment.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a procedure performed on (b)(6) 2018.The patient claims the following injuries as a result of the procedure: erosion, exposure, recurrence of abdominal pain, back pain, scarring, and removal surgery.Furthermore, the patient claims to have suffered the following damages as a result of the implantation of the lynx system device: physical pain, mental anguish, physical impairment, and medical care expenses.***additional information received on july 3, 2023*** the patient had a procedure on (b)(6) 2018, for urinary retention and stress urinary incontinence.The procedure included urethral lysis and insertion of a pubovaginal sling.A cystoscopy was done to check for any damage to the urinary tract and to ensure the needle was correctly positioned.The results showed no perforation and good needle placement.The patient has a history of urinary incontinence, as noted by the physician.In 1993, she underwent a "bladder tack" during a hysterectomy.In 2018, a sling was placed, but the patient experienced vaginal erosion and did not follow up with the urologist.The patient recently came to the office/clinic with continued incontinence and received an evaluation that included a urodynamic study, which revealed mixed urinary incontinence.The patient also has a small functional bladder capacity.A cystoscopy showed no issues and no erosion of the mid-urethral sling on the left side.Based on the medical report, it has been determined that the patient is primarily experiencing leakage related to stress.This prompted a consultation between the doctor, the patient, and her spouse to discuss potential treatment options.During the conversation, the physician thoroughly discussed the realistic expectations and the likelihood of overactive bladder symptoms persisting or worsening post-surgery.After weighing the available options, the patient ultimately decided to proceed with an autologous rectus fascia pubovaginal sling procedure.This procedure included the removal of exposed vaginal mesh, which was identified as a contributing factor to the patient's symptoms.On (b)(6) 2022, the patient underwent a surgical procedure to address two medical concerns: urinary incontinence and the presence of a foreign object in the vaginal area.During the procedure, it was noted that the left wing of the mid-urethral sling that had been previously placed had eroded, and the sling was situated in a distal position.To rectify this, a midline incision was made from the urethral meatus to the bladder neck, and the vaginal wall was detached from the urethra and bladder neck area.Once this was done, the patient's sling was isolated and completely mobilized to the entrance into the muscle bilaterally, ensuring that the issue was properly addressed.The sling was excised and handed off the field for pathologic evaluation.The endopelvic fascia was then opened bilaterally, and the retropubic space was bluntly developed.A 22-french scope with 30 and 70-degree lenses was used for rigid cystoscopy, and it was found that there were no signs of bladder perforation.The ureteral orifices were visible, and urine flow was noted, while the urethra was intact.The catheter was replaced with a 16 french foley catheter, and the sling was deployed by passing the prolene sutures through the suprapubic incision.The sling material was nicely placed over the mid to proximal urethra, and the prolene sutures were tied over the rectus fascia, positioned one fingerbreadth above the fascia.After waking up from anesthesia, the patient was taken to the recovery room in stable condition.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a procedure performed on (b)(6) 2018.The patient claims the following injuries as a result of the procedure: erosion, exposure, recurrence of abdominal pain, back pain, scarring, and removal surgery.Furthermore, the patient claims to have suffered the following damages as a result of the implantation of the lynx system device: physical pain, mental anguish, physical impairment, and medical care expenses.Additional information received on july 3, 2023.The patient had a procedure on (b)(6) 2018, for urinary retention and stress urinary incontinence.The procedure included urethral lysis and insertion of a pubovaginal sling.A cystoscopy was done to check for any damage to the urinary tract and to ensure the needle was correctly positioned.The results showed no perforation and good needle placement.The patient has a history of urinary incontinence, as noted by the physician.In 1993, she underwent a "bladder tack" during a hysterectomy.In 2018, a sling was placed, but the patient experienced vaginal erosion and did not follow up with the urologist.The patient recently came to the office/clinic with continued incontinence and received an evaluation that included a urodynamic study, which revealed mixed urinary incontinence.The patient also has a small functional bladder capacity.A cystoscopy showed no issues and no erosion of the mid-urethral sling on the left side.Based on the medical report, it has been determined that the patient is primarily experiencing leakage related to stress.This prompted a consultation between the doctor, the patient, and her spouse to discuss potential treatment options.During the conversation, the physician thoroughly discussed the realistic expectations and the likelihood of overactive bladder symptoms persisting or worsening post-surgery.After weighing the available options, the patient ultimately decided to proceed with an autologous rectus fascia pubovaginal sling procedure.This procedure included the removal of exposed vaginal mesh, which was identified as a contributing factor to the patient's symptoms.On (b)(6) 2022, the patient underwent a surgical procedure to address two medical concerns: urinary incontinence and the presence of a foreign object in the vaginal area.During the procedure, it was noted that the left wing of the mid-urethral sling that had been previously placed had eroded, and the sling was situated in a distal position.To rectify this, a midline incision was made from the urethral meatus to the bladder neck, and the vaginal wall was detached from the urethra and bladder neck area.Once this was done, the patient's sling was isolated and completely mobilized to the entrance into the muscle bilaterally, ensuring that the issue was properly addressed.The sling was excised and handed off the field for pathologic evaluation.The endopelvic fascia was then opened bilaterally, and the retropubic space was bluntly developed.A 22-french scope with 30 and 70-degree lenses was used for rigid cystoscopy, and it was found that there were no signs of bladder perforation.The ureteral orifices were visible, and urine flow was noted, while the urethra was intact.The catheter was replaced with a 16 french foley catheter, and the sling was deployed by passing the prolene sutures through the suprapubic incision.The sling material was nicely placed over the mid to proximal urethra, and the prolene sutures were tied over the rectus fascia, positioned one fingerbreadth above the fascia.After waking up from anesthesia, the patient was taken to the recovery room in stable condition.Additional information received on september 12, 2023.On (b)(6) 2018, the patient came for a follow-up checkup.The patient stated she had been doing a lot better and the estrogen cream prescribed at the last appointment really helped her.She did complain unable to control kidneys, has to wear a pad 24/7 and stated she could feel the mesh from the sling.It was reported that the incontinence type was considered mixed, stress, and urge.Incontinence occurred at no unusual times, several times nightly, while coughing, exercising, laughing, lifting, sneezing, with a sudden, random urge, with little control of bladder function.Urination was described as at any time.Clinical notes reported patient had good control with urge incontinence with oxybutynin 15mg and she was seeing improvement as well with estrogen cream.As for erosion, patient was offered repair, and she chose to continue estrogen and oxybutynin.On (b)(6) 2019, the patient presented having some issues with the bladder.Since bladder sling in (b)(6) 2018, continued to have mixed incontinence.In a physician note on (b)(6) 2019, the patient was advised not to do further treatment especially no surgery and to discontinue ditropan after a while to see if she should need it.History of present illness, the patient stated she had a hysterectomy in 1992 and at that time the urologist told her that she had a sling a year ago.He loosened the sling, the patient understood to put another sling in but was not clear.The patient was concerned and came to office to ask why the vaginal vault did not grow over the sling.On examination, it seemed to be a sling present vaginoscopy with a flexible cystoscope did not reveal an erosion.She had been on hormonal vaginal cream for 2 months.Patient is totally uninformed about what kind of procedure was done last year the gynecologist thought a sling was placed at that time, but patient stated that the sling that was existing was just cut so it was suggested to get the operative note.The urethra seemed to be well suspended she has a good urinary stream.Physician suggested to wait and see and if her urinary stress incontinence really bothers her a lot then to subject her to an intraurethral supple mucosal injections of pellets.On (b)(6) 2021, the patient presented complaining of leaking urine.She came for urogynecology evaluation of urinary incontinence without urgency.Her past medical history was notable for a history of pelvic surgery, menopause, and hysterectomy.The patient originally underwent a bladder tack at the time of a hysterectomy in 1993.She reported that after the sling in 2018, she could feel mesh.Estrace was recommended but did not see any improvement in her leakage.She had not returned to see her physician in several years.She reported recent ct scan was normal.Review of systems: patient admits headaches, sinus problems, high blood pressure, tingling or numbness, joint pain, neck pain, and back pain, hay fever and drug allergies.Physical examination showed abdominal obesity and bladder with mild cystocele present.Assessment: - urinary incontinence - nocturia - vaginal foreign body - gross hematuria on (b)(6) 2022, the patient underwent cystoscopy and noted a mesh erosion vaginally over the urethra.The cystoscope was removed, and the patient tolerated the procedure well.Assessment: - urinary incontinence - urinary frequency - urgency of urination - vaginal foreign body patient reported that she was most bothered by the stress urinary incontinence.The patient would like to proceed with removal of her mesh erosion in conjunction with autologous fascia pubovaginal sling.This will be her 3rd surgery.On (b)(6) 2022, patient came to further discuss surgical treatment.The patient was scheduled for anti-incontinence procedure and for autologous rectus fascia pubovaginal sling and removal of vaginal foreign body.She complained of stress leakage of urine and nocturia.Her symptoms have been present for years.Her pmh was significant for diuretic use and hypertension.Work-up had included cystoscopy, urodynamics, and pelvic exam - mild cystocele was present.She required 2 pads per day.Cystoscopy revealed mesh erosion vaginally over the urethra.Urodynamics revealed hypersensitive bladder with decreased capacity.She had significant instability with filling.No uninhibited contractions were noted.She did have sui.Her voiding diary revealed small functional capacities (75-200cc).She reported mixed leakage but had a lot of urgency.Review of systems: patients admits high blood pressure, heartburn, and back pain.Pathology report on (b)(6) 2022, showed squamous mucosal and subepithelial fibrous stromal tissue with embedded mesh and chronic inflammation.

Manufacturer Narrative

Blocks a4, a6, b5, b6, b7, and h6: patient codes have been updated based on the additional information received on september 12, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of june 27, 2018, was chosen as a best estimate based on the date of the mesh was implanted.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 implanting physician is: dr.(b)(6) (b)(6) hospital (b)(6).The physician who performed the revision surgery is: dr.(b)(6) (b)(6) health system (b)(6) block h6: the following imdrf patient codes capture the reportable events of: e2006 - used to capture the reported event of erosion and exposure.E0206 - used to capture the reported event of mental anguish.E1715 - used to capture the reported event of scarring.E2330 - used to capture the reported event of back pain and physical pain.E1302: hematuria e2326: inflammation e1308: urinary frequency e1308: urinary urgency e1308: tingling or numbness e2401: abdominal obesity e2313: fibrosis - fibrous tissue found in the mesh the following imdrf impact codes capture the reportable events of: f1903: device explantation - used to capture the reported event of removal surgery.F12: serious injury/ illness/ impairment - patient had filed a legal claim for injuries related to the device.F1202: disability - used to capture the reported event of physical impairment.Block 11: block b2 outcomes attrib to adv event has been corrected.

• 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: 17119505
• MDR Text Key: 317090213
• Report Number: 3005099803-2023-03047
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• 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; Disability
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: White