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

BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Back to Search Results

Model Number M0068502120

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

Patient Problems Fatigue (1849); Micturition Urgency (1871); Nerve Damage (1979); Pain (1994); Urinary Frequency (2275); Anxiety (2328); Numbness (2415); Prolapse (2475); Hematuria (2558); Unspecified Heart Problem (4454); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/15/2020

Event Type Injury

Manufacturer Narrative

Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: dr.(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.

Event Description

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.Surgeon: dr.(b)(6).Block h6: patient codes e2401, e0123, e2330, e1405, e1605, e232402 and e2333 capture the reportable events of pudendal neuralgia, pelvic pain, complex regional pain syndrome, dyspareunia, muscle spasticity, urinary incontinence, prolapse.Complication of implanted genitourinary material2.Impact codes f1903 and f1905 capture the reportable events of removing the entire sacrocolpopexy mesh and robotic assisted laparoscopic removal of retropubic mesh.

Manufacturer Narrative

Patient codes have been updated based on the additional information received on august 2, 2023.This event was reported by the patient's legal representation.The device was implanted by: surgeon: dr.(b)(6) assistant surgeon: dr.(b)(6), csfa (b)(6) medical center imdrf patient codes e2401, e0123, e2330, e1405, e1605, e232402, e2333, e1413 and e1302 capture the reportable events of pudendal neuralgia, pelvic pain, complex regional pain syndrome, dyspareunia, muscle spasticity, urinary incontinence, prolapse.Complication of implanted genitourinary material2, arousal disorder, and blood in urine.Imdrf impact code f1905 captures the reportable event of robotic assisted laparoscopic removal of retropubic mesh.Model number and catalog number, and section e.Initial reporter have been corrected.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure, the advantage fit blue system.Refer to manufacturer report # 3005099803-2022-05137 for the associated device information.It was reported to boston scientific corporation that an advantage fit blue system device and upsylon y-mesh device were implanted into the patient during a robotic supracervical hysterectomy + removal of fallopian tubes + sacrocolpopexy + midurethral sling + cystoscopy procedure performed on (b)(6) 2020 for urinary urgency, uterovaginal prolapse, acquired vaginal enterocele and female genuine stress incontinence.During procedure, findings showed intact bladder, ureters, urethra, rectum and normal ovaries left behind.It was noted that the patient had severe diffuse hypervascularity and mild trabeculations.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on november 3, 2022, november 11, 2022, and november 15, 2022.On (b)(6) 2020, immediately after surgery, the patient was in significant pain and thought that this pain was postsurgical pain.The pain was excruciating, and the patient complained to the physician about it; however, the physician suggested that the patient should wait for another 6 weeks to see if the pain will get better.Patient was mostly complaining of pain at the posterior fourchette at the right of the midline of the vulva.A gynecologist had told her that this may be due to neuropathic pain.The patient then found a physician who ordered one ct guided bilateral pudendal nerve block.The patient had immediate but temporary relief of pain and physician suggested pudendal neurolysis.The patient then went to see a gynecologist who ended up removing the entire sacrocolpopexy mesh but not removing the retropubic sling.Patient was told that the entire mesh was to be removed.The patient remembers waking up from surgery in exactly the same pain she had and being very emotional about it and was then scheduled for the removal of the sling; however, this procedure was not performed.The patient went back to see the physician and was scheduled for pudendal neurolysis.The pain was significantly worse with sitting and physical activity.In addition, the patient felt pain during intercourse to the point where the patient is no longer sexually active.According to the patient, the pain worsened after the removal of the sacral cervicopexy mesh and that there was no pain prior to the surgery from 2020 and the patient had significant prolapse but fairly little incontinence.Initially the pain was felt only on the right side of the buttocks; however, now, some pain is felt on the left.On (b)(6) 2020, post-procedure and via telemedicine visit, the following patient's questions and concerns were addressed.The patient had questions about the stitches, she reports that the stitch "feels like a needle" and that "things are poking out".She was assured by the physician that the stiches will dissolve and it is nothing to be concerned about.The patient noticed the vaginal atrophy was listed on her after visit summary and she was unaware that she had it.The physician explained that it means the lining is thin and vaginal estrogen cream is to help expedite the healing process.They explained that the vaginal tissue is thinner than desired for post sacrocolpopexy and hence the term "atrophy".On (b)(6) 2022, the consult was done via telemedicine with the following assessments and plans: the patient was assessed as having pudendal neuralgia, spastic pelvic floor syndrome, and complications due to genitourinary prosthetic materials.The patient will be scheduled for robotic assisted laparoscopic removal of advantage fit retropubic sling, check for any remaining mesh from sacral cervicopexy, burch procedure, uterosacral colpopexy, bilateral pudendal nerve block, and botox injection to pelvic floor muscles ((b)(6) units).On (b)(6) 2022, the patient returned for a physical exam and pre-operative visa.The patient continues to be in significant pain.During the visit, the patient was not able to sit due to pain and was standing all throughout the consultation.The patient had the following: bilateral lower back tenderness, abdominal tenderness with positive carnett's significant bilateral tenderness of pelvic floor muscles, an area of extreme tenderness at the right ischial spine, and on external exam, the patient has some hypersensitivity to touch on the right labia majora.On (b)(6) 2022, it was reported that a robotic assisted laparoscopic removal of retropubic mesh, uterosacral colpopexy, bilateral pudendal nerve block, botox injection to pelvic floor muscles, and burch procedure was performed to treat the following diagnoses: pelvic pain, complication of implanted vaginal mesh, pudendal neuralgia, spastic pelvic floor syndrome, and complex regional pain syndrome.A 2 cm incision in the anterior vaginal wall underneath the urethra was then made with a scalpel and blue colored mesh was immediately identified.Using sharp and blunt dissection if was separated from the urethra and vaginal epithelium and followed all the way on both sides to the pelvic floor and inferior edge of the pubic bone.When mesh was completely free it was divided in the center and both ends were placed in the kocher clams.There was significant bleeding encountered during this part of the procedure, and the vagina was packed with lap sponges.Robotic ports were placed as customary in the robot was docked.Abdomen and pelvis were surveyed with the findings described above.Bladder was then filled through the foley catheter with approximately 400 ml's of normal sterile saline.An incision superior/anterior to the bladder was then made and retropubic space was entered.Vessels in the retropubic area were sealed vessel sealer and transected.After further dissection left segment of retropubic mesh was identified against the posterior surface of the pubic bone.The entire left segment of the mesh was then separated from pubic bone, obturator internus muscles and surrounding structures.The care was taken to remove anterior attachment of the mesh to the rectus abdominis muscles.Small incision in the pelvic floor was then made connecting vaginal and retropubic parts.The entire left segment was removed without any mesh remaining on the left side.The right segment of the mesh was also identified.In a similar fashion the right segment of the mesh was also removed.There is no mesh remaining on the patient's right side.Small defects in the pelvic floor on the right and left sides were closed with the running sutures of 2-0 v-loco excellent hemostasis was noted.Peritoneum over the sacral promontory was then incised in vertical linear fashion until the anterior spinal ligament was identified.There was no evidence of mesh or any sutures in that area.Lucite rod was placed in the vagina and cervix was visualized.2-0 gore-tex suture was placed between the right edge of the cervix and right uterosacral ligament.The right ureter was visualized the entire time to make sure it is not being kinked by the suture.The same procedure was then done on the patients left side cystoscopy was then performed.Bladder and urethra were carefully inspected.There was no evidence of sutures or any injury to those organs.Patient tolerated the procedure well.She was taken to the recovery room in stable condition.Patient has been discharged with close outpatient follow up.On (b)(6) 2022, the patient's visit was done via telemedicine.Patient continues to be in pain and stated that her pain is almost unchanged from before the mesh removal surgery.Plan: 1.Pelvic floor physical therapy.2.If the therapist finds significant spasm of the pelvic floor muscles patient may be a candidate for botox injection to pelvic floor muscles (400 units) and bilateral pudendal nerve block.3.If no improvement patient may be a candidate for right transgluteal pudendal neurolysis.Additional information received on august 2, 2023 in an encounter on (b)(6) 2021, patient stated that the pain occurred suddenly and not gradually.It was constant and sharp, and predominantly located on the right.The pain was worse while sitting and felt better during intercourse.On a scale of 1--10, the patient's pain was 9.It was also reported that she used hydrocodone after the implant surgery in 2020 and for her pain.The pain was in territory of the pudendal nerve and the posterior femoral cutaneous nerve, from the anus to the perineum.The pain had not woken up the patient at night.She was experiencing pain with no objective sensory impairment.Previous treatment was nsaids for six weeks, but patient still continued to exhibit symptoms despite of the treatment.Patient also stated she had a history of urinary frequency and urgency.Assessments included other chronic pain and unspecified site of myalgia.Pelvic pain was likely secondary to neuropathic pain and myofascial pain syndrome.Patient with both central sensitization and peripheral sensitization leading to membrane hyperexcitability and upregulation of both the central nervous system and peripheral nervous system with a sympathetic component to pain.The patient returned to office on (b)(6) 2021, after retrieving her outside records and being reviewed.Her previous consultation reported she had a complicated case: she had severe pain shooting from the rectum and upper vagina to her lower back with a feeling of being suspended; she also had very bothersome superficial pain at the right labia with some right leg weakness and persistent clitoral arousal.Pertinent findings included no prolapse; bothersome to light touch over right labia and adductor crease; no leg weakness perceived on exam and no gait disturbance; introitus appeared normal with normal coaptation; cervix was mobile, well supported, nontender, 1 faint suture visible at 12 o'clock; vaginal walls palpated, was able to palpate leading edge of mesh on right side anteriorly behind bladder but nontender; vaginal walls did not appear tense or tender, they were palpated and found to be of normal elasticity; and alcocks canal was nontender bilaterally.Upon reviewing her records, the following were noted: 1.She had a bottom-up advantage sling performed.2.The y-mesh was intact and without free fluid or signs of infection on mri.3.Pudendal nerve was noted to be unremarkable.4.She complained of similar symptoms to now immediately after her surgery was completed.5.She had 2 pudendal nerve blocks performed which did not relieve any of her symptoms.She had appropriate surgeries performed and suffered an untoward consequence that the physician had not seen before.The patient had two distinct problems: her superficial pain and arousal disorder, and her deep vaginal pain radiating to lower back.The two implanted devices did not appear to be an acute mesh rejection or infection.The superficial symptoms were clearly stemming from some injury to the clitoral branch of the pudendal nerve.This can only be explained by the dissection and/or placement of the retropubic sling.The deeper vaginal and back pain could only be explained by the dissection and/or placement of the sacro colpopexy mesh.However, it was not certain that removal of either/or will result in relief.On (b)(6) 2022, the patient had a follow up visit for pelvic pain.This was two months status post removal of y-mesh and patient stated no improvement of pain.The entire retropubic sling (advantage) was palpated per a vaginal exam and no pain elicited at all.Right pudendal was exquisitely tender and caused residual pain to left buttock and upper posterior leg.Pros and cons of sling removal vs pudendal block vs pudendal release were discussed.Removal of the sling was suggested as it was the only foreign body remaining and may have clitoral branch involvement causing referred pain across the nerve region.Another pudendal block was also considered to determine if that was the source of all the pain.On (b)(6) 2022, the patient came with a chief complaint of pudendal pain.It was reported that she had mri of the pelvis that showed periurethral cyst, mucosal hypertrophy of the endocervical canal with small cysts, and simple right ovarian cysts.Since her last visit, she had couple of procedures to ease the pain including removal of the mesh and release of pudendal nerve by a plastic surgeon.The results were visible at this point and the pain was excessive and the pelvic area was mostly on the surface radiating inside the vagina and rectum.There was a considerable discomfort with sitting, standing, and bowel movements or bladder movements.Her activities were also limited due to the intensity of the pain.Any exertion was aggravating the pain tremendously.She had been on multiple medications and benzodiazepine seemed to be helping the most.Neuromodulation was discussed with the patient, but she was leery due to the experience she had with the mesh.Review of system: blood in urine.Palpitations.Fatigue.Numbness.Excessive urination.An encounter on (b)(6) 2022, reported that the patient came for medical clearance for pelvic nerve repair with allograft on (b)(6) 2022, for pelvic neurolysis.Assessment/plan included pelvic neurolysis, chronic pelvic pain and perineal pain.She had generalized anxiety disorder but overall stable; continue with xanax as needed.Last (b)(6) 2021, patient came to the same office for alprazolam refill.She was taking it to help with anxiety and to be able to sleep.No history of adverse surgical or anesthesia complications.She was able to walk more than four blocks and climb three flights of stairs without chest pain or shortness of breath.In an hpi note of (b)(6) 2021, it was stated that the patient was complaining of chronic pain in lower abdomen deep inside her vaginal area which she claims started after she had mesh put in place surgically.She stated she had been to a lot of specialists, and no one could help her unless she had a surgeon remove the mesh.

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

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

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

15378120

MDR Text Key

299452043

Report Number

3005099803-2022-05136

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729961925

UDI-Public

08714729961925

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K020110

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup

Report Date

08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

09/08/2022

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

05/12/2022

Device Model Number

M0068502120

Device Catalogue Number

850-212

Device Lot Number

0023780488

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

08/02/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

05/13/2019

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Other;

Patient Age

40 YR

Patient Sex

Female

Patient Weight

52 KG

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

Links on this page:

Links on this page: