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

Model Number M0068502110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572)

Event Date 05/24/2001

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) 2001.The patient claims to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product: infections, pelvic pain, back pain, failed sling, chronic interstitial cystitis, stress and urge incontinence, erosion of the mesh, and more to be determined in the course of discovery.Additionally, the patient also claims to have suffered damages as a result of the implantation of the prior designated pelvic mesh product, including economic damages such as medical bills, out-of-pocket expenses, and lost wages, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2001, 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) hospital.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2006 - erosion of mesh, e0206 - unspecified mental, emotional or behavioural problem, e1906 - infection, e2330 - pain, e2326 - chronic interstitial cystitis, e020201 - anxiety, e020202 - depression, e1304 - urinary urgency.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.

Manufacturer Narrative

Blocks a1, a2, b2, b3, b5, b7, e1 below and h6: patient codes and impact codes have been updated based on the additional information received on june 21, 2023.Block e1: this event was reported by the patient's legal representation.The implanting physicians are: dr.(b)(6).Revision surgeons: dr.(b)(6).Block h6: imdrf patient codes e2006, e0206, e1906, e2330, e2326, e020201, e020202, e1304, e211401, e1309, e1310, e232402, e1308, e1007, e1020 and e1032 capture the reportable events of erosion of mesh, unspecified mental, emotional or behavioural problem, infection, pain, pelvic pain, bladder pain, chronic interstitial cystitis, anxiety, depression, urinary urgency, bladder perforation, unable to void, recurrent utis, stress urinary incontinence, urinary frequency, constipation, nausea, and vomiting.Imdrf impact code f1905 captures the reportable event of 8cm portion of mesh removed.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a total vaginal hysterectomy + bilateral salpingo-oophorectomy + uterosacral vault suspension + perineorrhaphy + tension-free vaginal tape + cystoscopy procedure performed on (b)(6) 2021 for the treatment of uterovaginal prolapse and mixed urinary incontinence.Findings showed normal uterus, tubes and ovaries, bulky elongated cervix, and bilateral ureteral spill prior to and following tying vault suspension stitches.During the procedure, there was a perforation of the bladder bilaterally with tvt trocars repositioned prior to pulling the sling through and deploying.The patient tolerated the procedure well and was sent to the recovery room in good condition.The patient claims to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product: infections, pelvic pain, back pain, failed sling, chronic interstitial cystitis, stress and urge incontinence, erosion of the mesh, and more to be determined in the course of discovery.Additionally, the patient also claims to have suffered damages as a result of the implantation of the prior designated pelvic mesh product, including economic damages such as medical bills, out-of-pocket expenses, and lost wages, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.---additional information received on june 21, 2023--- in a progress note of december 6, 2021, the patient had complaints of recurrent utis and some pelvic pain since the surgery.She had been treated for possible ic (immune complex) or pbs (pancreas blood sugar) including bladder instillations.She stated she was unable to void and went to the emergency department where they put a catheter in for a week.She was seen by a urologist who did a cystoscopy and showed a normal bladder.Post-void residual in the office was minimally elevated and urinalysis was generally negative.She denied stress urinary incontinence at this time.She stated that she was concerned about the continued infections and that her body was rejecting the sling material.She had a positive culture, e.Coli.Assessment/plan: overactive bladder, recurrent uti, had bladder pain and some suggestion of recurrent infection since the implant, recently experienced urinary retention requiring catheterization, not responsive to treatment for ic or pbs, cysto with vaginal mesh excision was scheduled.On (b)(6) 2022, the patient underwent excision of vaginal portion of tvt mesh and cystoscopy due to overactive bladder, recurrent uti, and interstitial cystitis or painful bladder syndrome.When the sling had been completely freed to the pubic rami, it was placed under tension and excised.The remaining mesh was retracted back into the space of retzius.Cystoscopy was performed with the findings of normal appearing bladder with no cystotomy or foreign bodies, bilateral ureteral efflux, normal appearing urethra, and about 8cm of sling removed.Patient tolerated the procedure well and was sent to the recovery room in good condition.In a postoperative check, patient stated she felt great since the excision surgery.There was a slight spotting on the day of the procedure and a little bit of discharge.All sutures were dissolving but no other complaints.She stated she had no pain, had been voiding freely without difficulties, and denied urinary incontinence.She did notice when she had to void, she experienced urgency but at this point it is not bothersome.There were no dysuria or other signs of urinary infection.All bothersome preoperative symptoms had resolved.The patient was doing well postoperatively.In a progress note of (b)(6) 2022, status post excision of vaginal portion of tvt mesh secondary outlet obstruction and pelvic pain.Her pain and other complaints immediately resolved following the surgery.Initially she reported no stress urinary incontinence symptoms but some mild overactive bladder symptoms.In the months since her mesh excision, she had started to experience stress urinary incontinence with cough, sneeze and even walking.She was experiencing frequency and urgency.She felt like she needed to void all of the time and if she waited, she would experience urge urinary incontinence.She voided about every 30 minutes during the day and 3 times every night.Bowel movement were every evening.She stated that stool was soft, but she needed to strain to pass her bowels.Stress urinary incontinence was not surprising given her sling excision, but it was difficult to explain her worsening overactive bladder and urge urinary incontinence.A possible fascial sling or rpu (burch retropubic urethropexy) was discussed when the mesh was explanted but not until the other symptoms were resolved.Given worsening overactive bladder or urge urinary incontinence would hesitate to address stress urinary incontinence primarily.Patient was not experiencing the bladder pain that she previously described but still questioned some ic or pbs.Patient had been taking pyridium fairly regularly through primary care physician.Was getting voiding diary and schedule for multichannel urodynamics.The patient was taking medications for pain, nausea, vomiting and constipation.

• 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: 16795371
• MDR Text Key: 313822704
• Report Number: 3005099803-2023-02043
• 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: 07/18/2023

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 Expiration Date: 09/01/2023
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0025948871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female