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

Model Number M0068502111

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

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Anxiety (2328); Discomfort (2330); Depression (2361); Obstruction/Occlusion (2422); Dysuria (2684); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 03/24/2017

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 tension free vaginal tape + cystoscopy procedures performed on (b)(6) 2017 for the treatment of stress urinary incontinence, mild cystocele and minimal uterine prolapse.During insertion, there was a bladder perforation on the right side (approximately 0.7-10 mm.).There was no bleeding, but the blue plastic sheath could be seen coming through the bladder.The hook was then repositioned properly.The patient was transferred to the recovery room in stable condition.Upon discharge, the patient reported pain in pelvic area and wanted to pull the catheter out as she described it to be more painful than giving birth.On (b)(6) 2017, three days from the surgery, the patient presented to the emergency room (er) and complained of leakage around the catheter when voiding and pain.Ultrasound showed 5 cm left perivesicular fluid collection that could be a urinoma although nonspecific.The patient was treated for pain and her catheter was replaced.On (b)(6) 2017, one week post surgery, the patient presented to the er for significant suprapubic cramping followed by episodes of controlled of voiding despite having an indwelling foley catheter in situ.On examination, patient appeareds quite uncomfortable, but clinically stable.Reportedly, the urine was also coming out of the patient and in catheter at the same time.The 14 french foley was exchanged for an 18 french foley, and myrbetriq 50 mg p.O.Once daily was prescribed to decrease bladder spasms.A gynecology referral request dated (b)(6) 2017 stated that the patient complained of excessive whitish vaginal discharge associated with pelvic pain and difficulty voiding (she has to force the urine out when urinating).Recent urine culture was negative, and she was currently on marcrobid.Vaginal and cervical swabs were submitted for c&s, pelvic ultrasound scheduled in april 21 and was referred to urology.Doctor's note dated (b)(6) 2017, a genital smear was performed and microscopic showed bacterial vaginosis in patient.On an unspecified date, the patient was evaluated at 6 weeks post-op by a gynecologist and was advised there may be a stitch that had not dissolved or vaginal extrusion of mesh.There were no other findings.The patient was referred to a urologist.On (b)(6) 2017, the patient was evaluated by a urologist for pain with sexual function and dysuria (hurts to void, feels like an open cut).Ultrasound showed normal kidneys, bladder and normal bladder emptying.Bladder scan revealed 0 ml post-void residual (pvr).The diagnosis was noted as dysuria nyd (not yet determined).The plan was cystoscopy and pelvic exam with a repeat urinalysis and culture.On (b)(6) 2017, the patient underwent cystoscopy and vaginal exam for pain while voiding.Cystoscopy showed the bladder and urethra were completely normal and there was no erosion or obvious scar tissue from the previous intraoperative perforation noted.Vaginal exam showed no extrusion and no indication of problems with the sling position.The physician considered the possibility of bladder spasms causing pain with voiding, though the patient did not have any of the other symptoms that are normally associated with overactive bladder.The plan was to run a urinalysis and culture and start the patient on a course of myrbetriq with a recheck in august.On (b)(6) 2017, the patient filed for disability support program due to: severe abdominal pain after surgery , unable to do sit ups , cannot run , cannot even lift laundry basket , and patient stated this was expected to last less than a year, continuous and likely to remain the same.Activities that may require assistance to complete: ability to participate physically in sustained activity., walks three blocks or more on level ground without need to rest , climbs up or down one flight of stairs (six steps) , bowel and bladder control , and do housekeeping.On (b)(6) 2018, the patient was evaluated by her urologist.She had missed her follow-up the previous august and did not rebook her appointment until now.She reported a feeling of heaviness in her pelvis with a full bladder.She had not tried the myrbetriq previously recommended, and she had not had a repeat urine culture and sensitivity as previously recommended.She reported increased urgency with bladder pain and that she has had positive urine cultures, though the urologist had not seen those.She also reported a creaking sensation in her pelvis.Though the patient sensed she was not completely emptying, a bladder scan showed no residual.The patient was provided uti prevention advice, recommended to have a urine culture and sensitivity, and agreed to start myrbetriq.On (b)(6) 2018, the patient was evaluated by the urologist and reported that myrbetriq 50mg did not help her cramping or pelvic pain or feeling of urgency.It was also noted that she had a negative urine culture in may.The patient was to try trosec 20 mg twice daily with a recheck in 3 months.The ppatient wanted the sling to be removed but she was advised this was not possible without major complications.On (b)(6) 2018, the patient was seen by the urologist.A urinalysis and culture in september had shown no sign of infection.She did have a uti 3 weeks prior to this appointment.She also reported that the trosec had not helped and that pyridium did not resolve the sharp vaginal pain.On (b)(6) 2019, the patient was evaluated by the urologist for suspected overactive bladder.She reported that if she - cannot get to a bathroom in time, she has suprapubic pain, more on the left side.She had previously failed myrbetriq and trosec.She also reported pain around her left hip, down her anterior thigh, and a heavy feeling in her pelvis.The patient reported that if, she took pyridium for two days, 200mg twice daily for discomfort, then everything goes away.Urinalysis and culture, ct abdomen and pelvis, and possibly cystoscopy were recommended.On a clinical note on (b)(6) 2019, the patient's ct scan of abdomen and pelvis was reported to show a 3.5cm right adnexal cyst.She had a bulging disc near l5 but did not have any right back pain or sciatica.She still complained of left pelvic pain.The patient was referred to another urologist for possible cystoscopy and urodynamics.Additionally, the patient pleads that she has had trouble urinating, cannot sit or stand for prolonged periods of time, is unable to engage in sexual relations, and has suffered from severe pain, vaginal bleeding, depression and anxiety.As a result of having the mesh implanted, the patient has experienced significant physical, psychological and emotional pain and suffering, undergone surgeries and hospitalizations and has sustained permanent and debilitating injuries.

Manufacturer Narrative

This event was reported by the patient's legal representation.The implant surgeon is: (b)(6) (b)(4).The complaint device 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.

• 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): 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: 14672677
• MDR Text Key: 294853621
• Report Number: 3005099803-2022-02969
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729784777
• UDI-Public: 08714729784777
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2022

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: 05/20/2019
• Device Model Number: M0068502111
• Device Catalogue Number: 850-211
• Device Lot Number: 0000031788
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• 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 Sex: Female
• Patient Weight: 56 KG