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

Model Number M0068502120

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

Patient Problems Erosion (1750); Fatigue (1849); Incontinence (1928); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Discomfort (2330); Weight Changes (2607); Dysuria (2684); Unspecified Musculoskeletal problem (4535); Urinary Incontinence (4572)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of september 1, 2019 was chosen as best estimate since the first symptoms occurred "at the beginning of september '19".Block d4, h4: the reported lot number does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.Block h6: imdrf patient code (b)(6) captures the reportable event of razor-like pain.Imdrf patient code (b)(6) captures the reportable event of exposed mesh.Imdrf patient code (b)(6) captures the reportable event of nerve damage.Imdrf patient code (b)(6) captures the reportable event of dysuria with slow stream.Imdrf impact code (b)(6) captures the reportable event of difficulty in prolonged sitting and walking for too long and unable to lift leg to get into bathtub and needs obligatory help from her husband.Imdrf impact code (b)(6) captures the reportable event of revision of the exposed mesh.

Event Description

Note: this manufacturer report pertains to the first of two devices implanted in separate procedures.Procedure summary: it was reported to boston scientific corporation that an advantage fit blue system was implanted into the patient during a procedure performed on (b)(6) 2019.Event summary: at the beginning of september 2019, the first symptom the patient felt was a razor blade-type of pain in her vagina.Operative report performed on (b)(6) 2019: indication: mixed urinary incontinence predominant on exercise with sphincter hypotonia at bud.No dysuria, no rpm (remote patient monitoring).Failure of pelvic training.Ntvt mesh proposal.Cystoscopy shows a healthy bladder.The bladder emptied with the catheter.Vaginal closure with an overlock of polysorb 3/0.Operative report performed on (b)(6) 2019: indication: vaginal exposure of tvt (tension-free vaginal tape) mesh despite surgical revision three weeks after placement with collection.Terrain at risk with vaginal lichen.No signs of infection.No urethral involvement in fibroscopy, disabling symptoms with a permanent razor blade sensation in front of the exposed part.Proposal for removal of the mesh vaginally after consultation with physician (referent in functional urological surgery at the university hospital of grenoble).Vaginal preparation during the month prior to the procedure to improve the chances of healing.The middle part of the strip is exposed for about 2 cm.The retropubic arms are left in place.Solid vaginal closure with polysorb 2/0 overlock.Operative report performed on september 18, 2019: indication: exposure of tvt strip 3 weeks after application, possibly related to a vaginal scar disunion.There are no signs of infection.The proposal for a vaginoplasty was overlaid.The middle part of the strip is approximately 15 mm exposed.The vaginal wall on the lower edge of the disunion was released to give mobility.It was reported that there was an intervention for vaginoplasty.On november 19, 2019, razor blade-like type of pain was present in the vagina.Her urologist in annex wanted to remove the strip permanently, so he contacted a colleague in grenoble who specialized in functional surgery for women and was advised to remove only the visible part of the mesh; not removing it entirely.On (b)(6) 2020, a new surgery was performed to partially remove the mesh.Pain on the right side of the vagina was present.Operative report performed on april 1, 2020, two months before the removal of the sub urethral mesh tvt, the patient presented for the recent onset of vaginal pain.A complete gynecological examination with a speculum was performed.The physician could not find any visible abnormality in the vagina, with a perfectly obtained scarring of the vagina.Moderate pain was present on palpation of the right lateral side of the vagina.Pain is not located in the path of the mesh; however, a nerve may have been damaged during the placement of the sling or various revisions and surgical procedures ever since.She was advised to return in case the pain worsens, to perform infiltration with a local anesthetic test.She is due to see the physician again for the continuation of the treatment.Operative report performed on june 29, 2020: indication: the patient with stress urinary incontinence presents with urethral hypermobility.She has history of sub urethral exposure and several revisions.Urodynamic balance regains pressure of fence below pressure expected at her age.No abnormality of the filling phase and vagina scarring is now obtained.Indication of new tvt type mesh.New control with good visibility that no longer finds the perforation.The orifice of the puncture of the awl no longer bleeds.Tension-free strip placement and was closed.Post-operation follow-up: the patient to be seen again for consult on august 13, 2020.Recommended to perform full bladder flowmeter on arrival.The urethral probe is to be kept for three days due to small bladder perforation, and to be picked up by a home nurse on thursday, july 7, 2020.Operative report performed on june 29, 2020: indication: pt.Received tvt on june 29, 2020, with favorable outcomes.During clinical examination and palpation, the right arm of the sling is quite palpable in a cul-de-sac right without being exposed.Pt.Is sensitive to palpation at this location.There is an indication for vaginoplasty.Intervention: the strip is well palpated on the right, much less on the left.There are no vaginal strands.On june 29, 2020, a new intervention was performed for the placement of a new iterative tvt (tension-free vaginal tape), punctiform perforation with the right allene.Pain in the right side of the vagina, groin pain, and sciatica-type pain were present.There was dysuria with low stream, hence she needed to change position.There is no more sensation present when urinating; instead, the bladder is always leaking.Has extreme fatigue.On january 26, 2021, a new intervention was made following the erosion of the mesh.On march 3, 2021, the patient with sub urethral sling type tvt presented for consultation for stress urinary incontinence with sphincter hypotonia at urodynamic assessment.The intervention was complicated by prosthetic exposure.She had vaginal lichen before the procedure, with trophicity borderline vulvovaginal.The exposed part of the mesh was removed.Following the procedure, the vaginal healing had been perfectly achieved but the stress incontinence has recurred.The patient was referred to another physician for further treatment.A urodynamic balance had been updated and found an overall closing pressure lower than pressure expected with her age, i.E., persistent sphincter hypotonia.It was noted on this visit that on june 29, 2020, a sub urethral sling, tvt, was re-inserted.As a result, she returned to the intravaginal portion of the sling.During examination, there was no prosthetic exposure.On january 26, 2021, the physician performed a vaginoplasty to further cover the right arm of the band.On this day, the patient presented due to persistent discomfort on the right side.Has recurrent pain in the vagina next to the right side of the mesh and can be felt when walking and when prolonged sitting.A cystoscopy and gynecological examination were performed and has not identified any exposure of mesh in intravesical infection or prosthetic exposure in the vagina.Elective pain on palpation of the cul-de-sac right vaginal finger with respect to the right arm of the mesh was present.Due to the pain caused by the sling, further removal is necessary.The physician sought advice from another physician.In the case of removal of the sub urethral sling, it will take some time to achieve the complete healing needed, and at that time, a urodynamic assessment will be updated, and see what treatment could be offered to correct her incontinence.On july 5, 2021, the patient presented for elective pain, evolving a little bit by crisis.She is in little pain during nighttime.Neuropathic symptoms occur and persist for a few hours and amend spontaneously.She did not identify any other triggers except sitting.Continues vaginal trophic treatment in good doses.The incontinence spiral has a great chance of reappearing and will be complex to manage on her sphincter insufficiency.She is a little abdominal overweight.Impression: stiff leg., pain in groin, hip, and tailbone.Regular treatment by osteopathy and physiotherapy sessions actions taken in the healthcare facility for the care of the patient: follow-up to the description of the current condition on the urinary side, dysuria with slow stream, need to change position, and little or no sensation when urinating.Needs to have a keen hearing to hear if the bladder has finished giving out.Often, when she gets up, she is still urinating (complicated to manage at work because you have to change).Has to go on regular breaks she often wants to urinate.She is on neurontin.Currently followed by a physiotherapist 2 times per week.Treatment includes pain center, auriculotherapy sessions, tens, sick leave, return to work in therapeutic part-time, anti-depressant, and sessions with a psychiatrist.She is to continue with dietary changes and sports she is currently taking.The goal of losing weight and feeling better resumed.It was recommended to see her once a year to have a clinical review of the urination calendar.There is a certain degree of urgency that can also be improved with weight loss and a return to sport.Current patient status: persistent right-sided pain is present.The pain radiates from the right side of the vagina to the buttocks.Described as a shooting star with a different intensity during night and day, which goes down like sciatica.She has difficulty in prolonged sitting and walking for too long.At the end of the day, if there are too many requests, she cannot lift her leg to get into my bathtub and needs obligatory help from her husband.

• Brand Name: ADVANTAGE FIT BLUE 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18535044
• MDR Text Key: 333133047
• Report Number: 2124215-2023-75470
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502120
• Device Catalogue Number: 850212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Disability