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

Model Number M0068502110

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

Patient Problems Adhesion(s) (1695); Fever (1858); Micturition Urgency (1871); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 03/15/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6), 2021.The patient claims to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product: pelvic pain; dyspareunia; vaginal pain; and other chronic complications of mesh.Additionally, the patient also claims to have suffered the following damages as a result of the implantation: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Moreover, the patient's medical needs are ongoing.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e1405 - dyspareunia.E2401 - other chronic complications of mesh.E0206 - emotional distress.E2330 - pelvic pain and vaginal pain.E2308 - disfigurement.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for the injuries related to the device.F23 - patient's medical needs are ongoing.

Manufacturer Narrative

Block h2: additional information: blocks a2 (date of birth), b5 (event description), d6b (explant date) and h6 (patient codes, impact codes and device codes) has been updated based on the additional information received on june 26, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).(b)(6).The physician who performed the revision is: dr.(b)(6).(b)(6).The physician who performed the mesh removal is: dr.(b)(6).(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1405 - has been used to capture the reported event of dyspareunia.E2401 - has been used to capture the reported event of other chronic complications of mesh.E0206 - has been used to capture the reported event of emotional distress.E2330 - has been used to capture the reported events of pelvic pain and vaginal pain.E2308 - has been used to capture the reported event disfigurement.E2311 - has been used to capture the reported event of discomfort.E1310 - has been used to capture the reported event of recurring urinary tract infections.E1310 - has been used to capture the reported event of burning sensation during urination.E1906 - has been used to capture the reported event of bacterial vaginosis.E1309 - has been used to capture the reported event of urinary retention.E1309 - has been used to capture the reported event of consistent "obstruction" in uroflow test.E1311 - has been used to capture the reported event of voiding dysfunction.E1715 - has been used to capture the reported events of scar tissue.E1301 - has been used to capture the reported event of dysuria.E2101 - has been used to capture the reported event of severe pelvic adhesive disease.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for the injuries related to the device.F23 - patient's medical needs are ongoing.F2303 - has been used to capture the reported event of patient had to take multiple antibiotics to address her recurring urinary tract infections.F1905 - has been used to capture the reported event of patient had undergone sling revision on (b)(6) 2022.F1903 - has been used to capture the reported event of mesh removal on (b)(6) 2023.F2203 - has been used to capture the reported event of patient of had a ct scan of her pelvis.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2021.The patient claims to have suffered the following injuries due to the implantation of the prior designated pelvic mesh product: pelvic pain; dyspareunia; vaginal pain; and other chronic complications of mesh.Additionally, the patient also claims to have suffered the following damages as a result of the implantation: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Additional information received on june 26, 2023.The patient received various medical procedures on (b)(6) 2021, including a total laparoscopic hysterectomy, laparoscopic bilateral salpingectomy, laparoscopic uterosacral ligament suspension, anterior repair, posterior repair, perineorrhaphy, transvaginal tape sling, cystoscopy, and urethroscopy.These procedures addressed the patient's uterine fibroids, menometrorrhagia, stage 2 cystocele, stage 3 rectocele, stage 3 uterine prolapse, stress urinary incontinence, and acute or chronic anemia.According to reports, the patient was stable after the procedures.Moreover, the patient was doing well.She is currently free from discomfort, and her pain is effectively managed without needing a foley catheter, which previously caused considerable discomfort and abdominal distension.A patient presented at the clinic on (b)(6) 2021, with symptoms suggestive of a urinary tract infection (uti).The patient's recovery following surgery has been complicated by the development of a uti.Initially, nitrofurantoin was prescribed, but the patient did not experience improvement, and subsequently, cipro was prescribed.While the patient initially improved, they later developed urgency symptoms.Following two weeks of myrbetriq 25mg po, the dosage was increased to 50mg, but the patient was recently diagnosed with a new uti and began treatment with cipro 500mg bid.However, the patient has not experienced any improvement.They deny symptoms such as fevers, chills, nausea, vomiting, back pain, or hematuria.The patient reports experiencing burning of the urethra and groin pain, which they describe as an ache, but denies any vaginal bleeding or pain.The patient has expressed feelings of discouragement due to their recovery from the mid-urethral sling procedure, despite a successful hysterectomy.A patient visited the clinic on (b)(6) 2021, complaining of burning during urination.Her post-operative recovery was complicated by urinary tract infections and persistent urgency, despite having tried myrbetriq and anticholinergics.However, her urgency symptoms have since resolved, and she and her husband had previously tested positive for chlamydia and were treated in (b)(6).She has had recurrent diagnoses of urinary tract or bacterial vaginosis infections after her surgery, and although referred to urology several times, she reports feeling better and doesn't attend appointments.Her last visit was in october, where she was diagnosed with an e coli urinary tract infection that was resistant to several antibiotics, and she was switched to macrobid.She has intermittently experienced symptoms and has taken three courses of nitrofurantoin.She reports no more urgency symptoms but experiences a burning pain outside the urethra, which is worse after running.She also experiences pain while urinating and at other times.The patient's pelvis exhibits tenderness in the anterior wall area.On (b)(6) 2021, the patient and her husband visited the clinic for an evaluation.She reported experiencing urinary symptoms since her surgery in (b)(6) 2021, which involved sling placement.After the surgery, she experienced urinary retention and needed a foley catheter for one week.Although she passed a trial of void in the clinic, she still experiences weak and intermittent streams, hesitancy, and double voiding.Additionally, since the surgery, she has developed new urinary frequency, urgency, and nocturia.She did not report experiencing any overactive bladder symptoms prior to the surgery.The patient reported experiencing ongoing difficulty with voiding, including a weak stream, on (b)(6) 2022.There have been no urinary tract infections since starting prophylactic treatment, and the patient is currently using vaginal estrogen.The results of her cystoscopy show no foreign objects or abnormal tissue present.During the procedure, there was a noticeable tenderness in the bladder neck region and an elevation of the area.However, her cystometrogram (cmg) indicates a potential blockage in the urine outflow with signs of voiding dysfunction.Additionally, her uroflow test is consistent with the obstruction.Moreover, treatment options were discussed and reviewed to address the issue.The patient was keen on going ahead with the sling excision.The doctor thoroughly discussed the potential risks and benefits of undergoing surgery.It is possible that the surgery may not fully alleviate her lower urinary tract symptoms, especially since some dysfunctional voiding was identified during testing.The doctor also mentioned that there is no guarantee that the surgery will address dyspareunia, as any vaginal surgery carries the risk of causing pain during intercourse.Other risks associated with the surgery include urinary incontinence, pain, scarring, potential damage to surrounding structures (the urethra was specifically mentioned and a foley catheter may be needed), and the risks associated with anesthesia.The area where the mesh underneath her urethra will be removed is the only area that can safely be excised, as removing the remainder of the mesh that is scarred in place could cause complications.An email from the patient on (b)(6) 2022, said her doctor found her sling was too tight and needs to be cut.On (b)(6) 2022, a surgical intervention was conducted to address an outlet obstruction caused by a mid-urethral sling in a patient.The procedure involved a mid-urethral incision with a mesh excision.There were no injuries to the urethra or bladder during the procedure or dissection.The removal of the patient's transvaginal tape mesh from underneath the urethra was successful, with the excision being carried out from the right to the left fornix.The mesh sling was found to be closer to the urethra on the left side compared to the right.The procedure was well-tolerated by the patient, who did not experience any complications and was subsequently transferred to the post-anesthesia care unit in a stable condition.The patient was referred for recurrent urinary tract infections on (b)(6) 2022.She reports that she experiences these infections monthly, causing dysuria, increased frequency, and urgency.To alleviate her symptoms, she has had to take multiple courses of antibiotics.While in mexico, she developed a fever and received intramuscular antibiotic therapy until returning to the united states.Prior to her hysterectomy, she experienced 1 to 2 urinary tract infections per year, usually related to intercourse.The patient travels frequently and admits to getting infections often when traveling internationally.She experiences dyspareunia over her mid urethra but no vaginal bleeding or partner discomfort during intercourse.Since her surgery, the patient has seen a significant improvement in urinary symptoms, with only one instance of nocturia per night.She also reports no incontinence or hesitancy and states that urination is great.The patient has reported experiencing bladder irritation, intermittent burning since (b)(6) 2022, and recurrent urinary tract infections.The physician has suggested the option of laparoscopically removing the residual sling.However, caution must be taken as the sling may be embedded in the bladder wall, thus necessitating a catheterization period after the procedure.Additionally, removing the sling may result in incontinence returning.On (b)(6) 2022, the patient reported that she had pain with intercourse.On (b)(6) 2022, the patient reported experiencing a recurring urinary tract infection, accompanied by discomfort in the groin area and a burning sensation during urination.The patient indicated a baseline pain level of 3 out of 10 in the absence of uti, with a level of activity rated at 7 out of 10, and a level of pain during intercourse rated at 8.5 out of 10.The patient has reported experiencing urinary leakage during physical activity, despite having emptied her bladder beforehand.This issue began after undergoing a uterine ablation procedure to alleviate abnormal uterine bleeding, which proved unsuccessful.Following this, the patient underwent a hysterectomy and was subsequently diagnosed with a uterine prolapse.Prior to this diagnosis, she had not experienced any urinary leakage.Over the past five weeks, the patient has experienced a burning sensation, frequent urination, and pain, for which she sought medical attention.Her physician prescribed myrbetriq, but after 2.5 weeks of taking it, the patient experienced no significant improvement.As a result, the physician increased the dosage to 50mg and diagnosed her with a urinary tract infection (uti).Antibiotics (nitrofurantoin and cipro) were prescribed, but after four days, the patient reported no improvement.The physician has referred her to a urologist.The patient suspects that the pain may be related to the mesh and its placement.Her current physician informed her that the pain may not completely subside, but based on her experience and symptoms, there is a greater than 95% chance of relief if the entire sling is removed.On (b)(6) 2023, underwent a transvaginal sling revision, laparoscopic sling removal, laparoscopic pelvic scar tissue removal, and cystoscopy procedures to address the following symptoms: 1.A history of a tension-free vaginal tape sling.2.Left and right lower quadrant pelvic pain.3.Vaginal pain.4.Dyspareunia.5.Pelvic and perineal pain 6.Chronic pain since the previous surgical procedure.7.Mesh pain due to genitourinary device.8.Severe pelvic adhesive disease, i.E., scar tissue.Transvaginal sling revision - during the procedure, the medical team administered 0.25% lidocaine with epinephrine to the suburethral and periurethral areas.They then created a vertical midline skin incision and carefully moved the vaginal epithelium on both sides.Once they placed a lone star retractor, they were able to locate the sling.From there, they dissected the sling from the urethral area, pubocervical fascia, and vaginal epithelium on both sides.After locating and removing the mesh in this area, they took photos for later reference.The team then proceeded to close the vaginal epithelium.Next, they focused on the laparoscopic portion of the procedure.Laparoscopic pelvic scar takedown - during the procedure, an open laparoscopy was conducted in the infraumbilical region.Three additional ports were placed under direct observation.The bladder was filled with retrograde and the space of retzius was entered with sharp dissection using a ligasure.The peritoneum between the obliterated umbilical folds was removed, and the mesh was carefully extracted from the anterior abdominal wall.However, the scar tissue that had accumulated since the previous placement of the sling had to be removed along with the mesh.The mesh was removed from the abdominal wall without causing any bleeding.The entire mesh had to be removed as it was embedded in the wall.Scar tissue was cleared before the tvt sling was taken out.Transvaginal tvt sling removal - the doctor proceeded with utmost care to remove the mesh from the pubic bone after releasing the sling on both sides and carefully pulling down the mesh from the anterior of the abdominal wall.The procedure involved meticulous dissection of the iliopectineal line, cooper's ligament, the obturator internus muscle, and the pubocervical fascia from the bladder on both sides, as well as the urethra.Following this, the pubocervical fascia was resected on both sides, and hemostasis was secured.The vesicoperitoneal reflection was then closed using 0-monocryl suture before concluding with cystoscopy and administration of pyridium.Cystoscopy with pyridium - no evidence of exudate, diverticulum, or malignancy.No evidence of needle penetration or trauma to the bladder or urethral mucosa.Bilateral ureteral patency was confirmed.The patient was then sent to the recovery room in stable condition.On (b)(6) 2023 the patient sent her own urine and a vaginal swab to microgen.The results demonstrated no vaginal pathogens.Less than 10,000 esbl e.Coli were noted.The patient completed a course of nitrofurantoin and has been seen by the infectious disease specialist who prescribed fosfomycin.She takes every 3 days and by the second day after a dose of fosfomycin she feels that her symptoms are recurring.On (b)(6) 2023, a patient sought consultation at the clinic regarding a complex urological issue.The patient reported experiencing improved dyspareunia since the removal of her sling on (b)(6) 2023.However, the patient is currently experiencing stress incontinence, which is particularly apparent during running, leading her to discontinue this activity altogether.The patient has noted a significant decrease in hesitancy since the placement of the sling, although some hesitancy persists.The patient has been experiencing recurrent urinary tract infections, which have required her to take multiple courses of antibiotics.However, she is concerned that these treatments may be affecting her culture results as she is often treated before the urine cultures have been obtained.The patient in question has previously attempted to treat her condition with d-mannose, while a ct scan of her pelvis in february revealed no abnormalities.She has been taking hiprex and vitamin c continuously and is also making use of vaginal estrogen.During the consultation, the patient expressed heightened emotions and a sense of being unheard.The doctor allowed her time to express herself and provided empathetic support.While she is experiencing stress incontinence, her main focus is addressing recurring urinary tract infections.Review of systems: genitourinary: positive for frequency, nocturia, urgency, and urinary incontinence.Musculoskeletal: positive for arthralgias and back pain.All other systems reviewed and are negative.

• Brand Name: ADVANTAGE FIT 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: 16795632
• MDR Text Key: 313825718
• Report Number: 3005099803-2023-02039
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• 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,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0026144282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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