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 Micturition Urgency (1871); Pain (1994); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Dizziness (2194); Hernia (2240); Urinary Frequency (2275); Prolapse (2475); Hematuria (2558); Dysuria (2684); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)

Event Date 11/20/2019

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a bsc tension free vaginal tape was implanted into the patient during a procedure performed on (b)(6) 2017 to treat stress urinary incontinence.Patient had a difficult delivery of her first baby and tore.She had a 3rd degree tear and her urinary problems started then.On (b)(6) 2019, patient had a total removal of tvt mesh due to concerns of the mesh, uti and sepsis.Since the surgery, her incontinence had increased a great deal.Was waiting to go back to the facility where the mesh was removed but patient would like to be referred to a local urogynecologist as she would not be unable to keep going back and forth to that facility.In a letter dated april 23, 2020, telephone follow up with the patient post procedure of mesh removal in november.Concerns about a lump in the left groin were discussed, a general practitioner had diagnosed a small hernia.The urology nurse practitioner communicated to the patient that if it needed fixing, there would be a choice of using mesh or dissolvable sutures but unfortunately, they often fall and hernia comes back.Patient wanted hernia surgery done at the same time as incontinence surgery; however, due to covid restrictions, video urodynamics was not possible and without it, procedure plan could not be decided.During a telephone consultation with a continence advisor on (b)(6) 2020, it was confirmed that she suffered from significant urinary incontinence since total removal of tvt last november.The assessment revealed that she had mixed urgency, stress incontinence and overactive bladder.The patient was then advised to correctly do pelvic floor exercises and commence bladder training as she was voiding quite frequently.In a telephone consultation on (b)(6) 2020, the patient was very unhappy as symptoms were not clearing despite the treatment.In this encounter, the patient was feeling a bit sick and dizzy.Outcome recorded: perineal irritation does have shooting pains sometimes always leaks when standing up, walking uphill or exercising gets up twice nocte but not wet so much at night.Always wets if does not get to toilet immediately.Always urgent when needs to pass urine.In a letter dated june 16, 2020: the patient was referred for consultation of a left sided inguinal hernia.The patient believes that the hernia resulted from tvt removal.The patient problem list was reviewed at follows: (b)(6) 2017: introduction of tension free vaginal tape.(b)(6) 2019: total removal of tension free vaginal tape.In an office visit on (b)(6) 2020, utis were not a problem anymore.Urodynamic findings showed blood trace in the urine sample.Patient was also diagnosed with urodynamic stress incontinence and urethral hypermobility.Plan discussed were supervised pelvic floor exercises, surgery for stress incontinence options and ct scan for hernia assessment requested.Patient would like hernia repair at the same time as sui surgery.On october 27, 2020, notes stated that recent urodynamic study showed stress incontinence, patient also had inguinal hernia and prolapse.She was on a waitlist for colposuspension and repair but no date yet.Patient was advised to continue with pelvic floor exercise.On (b)(6) 2020, patient presented with a swelling in her left groin which was related to the transverse incision, an incisional hernia rather than an inguinal hernia.She first noticed in february or march this year which came on after an episode of whooping cough.The swelling had increased slightly in size over the last six months.It disappeared when she laid flat and reappeared when she stood up.Her urinary symptoms had significantly improved since removal of the tvt and, although she still had stress incontinence, she had not had a recurrence of the utls she was struggling with prior to the tvt removal.On april 15, 2021, it was reported that the patient was very pleased the mesh has been removed and she had not had any infection since.Her main issue was the recurrent stress incontinence and two small incisional hernias.At the time of mesh removal, they had to perform an incision of the rectus sheath as the mesh was not felt above the rectus sheath and therefore had to be found from the inside of the pelvis and then followed upwards to the above of rectus sheath.The incisional hernias can probably be repaired with sutures.Suggested to have an autologous fascial sling and would use dissolvable sutures to put that in place.On june 24, 2021, it was stated in the letter that since the tvt mesh removal in 2019, she had had worsening symptoms from incisional hernias either side of her pfannenstiel incision.Patient was due for further surgery for autologous sling to treat urinary incontinence.She was unable to undertake exercises due to incisional hernias.Her situation was affecting her qualify of life, but otherwise, fit and healthy and takes no medication.Pfannenstiel incision was seen well - healed in the examination of the abdomen.At the left side of the scar, appeared to be a 2cm soft reducible incisional hernia.There was no obvious lump on the right side but there was still a definite cough impulse.Ct scans dated (b)(6) 2020 were reviewed and reported bilateral incisional hernias, the left is larger than the right.The patient was suffering from a symptomatic incisional hernia.She would like to undergo surgical repair but was not keen on further mesh insertion.As the hernias are small, patient would be suitable for a suture repair, and this would be a nylon suture.On march 5, 2022, it was stated in the letter that when the patient was 14 weeks post procedure of mesh removal on (b)(6), she had terrible stress urinary incontinence.When she was 6 weeks post procedure, she also got bronchitis and was coughing a lot and this had made her incontinence worse.She was leaking at night; was using around eight pads a day and she was trying to double void.Sometimes, she felt she was not emptying her bladder and was then advised to urinate and self - catheter once just to see if there was any residual.She was then referred for urodynamics to check her bladder now that she had her mesh removed.On (b)(6) 2022, patient had an urgent appointment for uti, had been very well since mesh was removed; however, patient experience pain on passing urine.Examination showed urine offensive, slight cloudy, nitrates and leucocytes.It was suspected uti.On (b)(6) 2022, the patient presented for an examination.The patient reported two utis since january which she had not had prior to mesh removal.She mentioned a pressure sensation on bladder and a feeling of something pressing down.Examination showed no evidence of prolapse and no palpable masses.The patient is worried about prolapse and is awaiting sling surgery.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019, the date of total mesh removal, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter name and address: this event was reported by the patient's legal representation.The explant surgeon is: dr.(b)(6).(b)(4).

Manufacturer Narrative

Block a1: as per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient's initials and date of birth will not be reported.Block b3 date of event: date of event was approximated to (b)(6) 2019, the date of total mesh removal, as no event date was reported.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 explant surgeon is: dr.(b)(6).(b)(6) institute.(b)(6).Block h6: patient codes e1309, e1310, e232402, e1720, e2330, e0306, e2319, e1302 and e1301 capture the reportable events of not emptying bladder, uti, recurrent urinary incontinence, perineal irritation, shooting pain, sepsis, incisional hernias, blood trace in urine sample and pain on passing urine.Impact codes f19 03 and f1901 capture the reportable events of total mesh removal and surgery for incisional hernias and stress urinary incontinence.Block 11: blocks a1, a2 patient identifier, dob and age; block b5 and section d suspect medical device have been corrected.

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) 2017 to treat stress urinary incontinence.Patient had a difficult delivery of her first baby and tore.She had a 3rd degree tear and her urinary problems started then.On (b)(6) 2019, patient had a total removal of advantage mesh due to concerns of the mesh, uti and sepsis.Since the surgery, her incontinence had increased a great deal.Was waiting to go back to the facility where the mesh was removed but patient would like to be referred to a local urogynecologist as she would not be unable to keep going back and forth to that facility.In a letter dated april 23, 2020, telephone follow up with the patient post procedure of mesh removal in november.Concerns about a lump in the left groin were discussed, a general practitioner had diagnosed a small hernia.The urology nurse practitioner communicated to the patient that if it needed fixing, there would be a choice of using mesh or dissolvable sutures but unfortunately, they often fall and hernia comes back.Patient wanted hernia surgery done at the same time as incontinence surgery; however, due to covid restrictions, video urodynamics was not possible and without it, procedure plan could not be decided.During a telephone consultation with a continence advisor on (b)(6) 2020, it was confirmed that she suffered from significant urinary incontinence since total removal of tvt last november.The assessment revealed that she had mixed urgency, stress incontinence and overactive bladder.The patient was then advised to correctly do pelvic floor exercises and commence bladder training as she was voiding quite frequently.In a telephone consultation on (b)(6) 2020, the patient was very unhappy as symptoms were not clearing despite the treatment.In this encounter, the patient was feeling a bit sick and dizzy.Outcome recorded: perineal irritation does have shooting pains sometimes.Always leaks when standing up, walking uphill or exercising.Gets up twice nocte but not wet so much at night.Always wets if does not get to toilet immediately.Always urgent when needs to pass urine.In a letter dated june 16, 2020: the patient was referred for consultation of a left sided inguinal hernia.The patient believes that the hernia resulted from tvt removal.The patient problem list was reviewed at follows: (b)(6) 2017: introduction of tension free vaginal tape.(b)(6) 2019: total removal of tension free vaginal tape.In an office visit on (b)(6) 2020, utis were not a problem anymore.Urodynamic findings showed blood trace in the urine sample.Patient was also diagnosed with urodynamic stress incontinence and urethral hypermobility.Plan discussed were supervised pelvic floor exercises, surgery for stress incontinence options and ct scan for hernia assessment requested.Patient would like hernia repair at the same time as sui surgery.On (b)(6) 2020, notes stated that recent urodynamic study showed stress incontinence, patient also had inguinal hernia and prolapse.She was on a waitlist for colposuspension and repair but no date yet.Patient was advised to continue with pelvic floor exercise.On (b)(6) 2020, patient presented with a swelling in her left groin which was related to the transverse incision, an incisional hernia rather than an inguinal hernia.She first noticed in february or march this year which came on after an episode of whooping cough.The swelling had increased slightly in size over the last six months.It disappeared when she laid flat and reappeared when she stood up.Her urinary symptoms had significantly improved since removal of the tvt and, although she still had stress incontinence, she had not had a recurrence of the utls she was struggling with prior to the tvt removal.On (b)(6) 2021, it was reported that the patient was very pleased the mesh has been removed and she had not had any infection since.Her main issue was the recurrent stress incontinence and two small incisional hernias.At the time of mesh removal, they had to perform an incision of the rectus sheath as the mesh was not felt above the rectus sheath and therefore had to be found from the inside of the pelvis and then followed upwards to the above of rectus sheath.The incisional hernias can probably be repaired with sutures.Suggested to have an autologous fascial sling and would use dissolvable sutures to put that in place.On june 24, 2021, it was stated in the letter that since the mesh removal in 2019, she had worsening symptoms from incisional hernias either side of her pfannenstiel incision.Patient was due for further surgery for autologous sling to treat urinary incontinence.She was unable to undertake exercises due to incisional hernias.Her situation was affecting her qualify of life, but otherwise, fit and healthy and takes no medication.Pfannenstiel incision was seen well - healed in the examination of the abdomen.At the left side of the scar, appeared to be a 2cm soft reducible incisional hernia.There was no obvious lump on the right side but there was still a definite cough impulse.Ct scans dated (b)(6) 2020 were reviewed and reported bilateral incisional hernias, the left is larger than the right.The patient was suffering from a symptomatic incisional hernia.She would like to undergo surgical repair but was not keen on further mesh insertion.As the hernias are small, patient would be suitable for a suture repair, and this would be a nylon suture.On (b)(6) 2022, it was stated in the letter that when the patient was 14 weeks post procedure of mesh removal on (b)(6) 2019, she had terrible stress urinary incontinence.When she was 6 weeks post procedure, she also got bronchitis and was coughing a lot and this had made her incontinence worse.She was leaking at night; was using around eight pads a day and she was trying to double void.Sometimes, she felt she was not emptying her bladder and was then advised to urinate and self - catheter once just to see if there was any residual.She was then referred for urodynamics to check her bladder now that she had her mesh removed.On (b)(6) 2022, patient had an urgent appointment for uti, had been very well since mesh was removed; however, patient experience pain on passing urine.Examination showed urine offensive, slight cloudy, nitrates and leucocytes.It was suspected uti.On (b)(6) 2022, the patient presented for an examination.The patient reported two utis since january which she had not had prior to mesh removal.She mentioned a pressure sensation on bladder and a feeling of something pressing down.Examination showed no evidence of prolapse and no palpable masses.The patient is worried about prolapse and is awaiting sling surgery.

• 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: 15807400
• MDR Text Key: 303757948
• Report Number: 3005099803-2022-06776
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729784777
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/13/2022

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 Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/13/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 60 KG