MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068505110

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

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Erosion (1750); Chest Pain (1776); Fatigue (1849); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Numbness (2415); Sleep Dysfunction (2517); Dysuria (2684); Constipation (3274); Paresthesia (4421); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Decreased Appetite (4569); Urinary Incontinence (4572)

Event Date 10/04/2019

Event Type Injury

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021, the date of the revision of prosthetic vaginal graft by vaginal approach, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).The revision surgeon is: dr.(b)(6).(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure 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 b3 date of event: date of event was approximated to january 12, 2021, the date of the revision of prosthetic vaginal graft by vaginal approach, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).The revision surgeon is: dr.(b)(6).(b)(6).Block h6: patient codes e2330 and e0123 capture the reportable events of pain and nerve damage (for levator spasms and pudendal neuralgia), respectively.Impact code f23: unexpected medical intervention has been used to capture pudendal nerve injections.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5 and h10 have been updated based on the additional information received on january 17, 2023.Block e1: this event was reported by the patient's legal representative.The patient's new legal representative is: atty.(b)(6).The implant surgeon is: dr.(b)(6).The revision surgeon is: (b)(6).

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a robotic-assisted sacrocolpopexy (with restorelle y contour mesh), transobturator sling placement, laparoscopy, and colpopexy procedure performed on (b)(6) 2019, for the treatment of pelvic prolapse, stress urinary incontinence and midline cystocele.The patient was transferred to pacu in stable condition at the conclusion of the implant procedure and findings include pelvic prolapse.On (b)(6) 2019, the patient had an office visit with complaints of chronic pelvic pain and chronic pelvic cramping.The patient rated pain 10 out of 10, but subjectively, she did not appear uncomfortable at all.Also, she had generalized weakness, and she still reports some urinary leakage with activity.The patient had a pelvic exam at her last visit that showed no evidence of any mesh erosion.The patient's objective description of her symptoms was very vague.Given the patient's history and that she had chronic pelvic pain and stress incontinence despite appropriate treatment, the physician suggested that the patient would benefit from pelvic floor rehabilitation to address her problem.On (b)(6) 2020, the patient presented with pelvic pain that had been ongoing for several months, and the specified point of tenderness was over the right side of the pubic symphysis.She also had dysuria, with cloudy urine and burning with urination.The patient had yellow vaginal discharge and an odor.She still had urinary problems even after her history of hysterectomy, repeat surgery for scar tissue, and removal of one fallopian tube and one ovary, wherein she had a lot of pain when she needed to urinate, and it felt like a "vice grip." during the patient's review of her system, it was mentioned that she was losing sleep and had a positive flatus but had bowel movements only about once weekly.Furthermore, the patient's active problem list included posttraumatic stress disorder, chronic pain syndrome, and major depressive disorder (recurrent, mild); the onset dates were not noted but appeared to be prior to the obtryx ii implant given the rest of the medical history.During the physical examination of the patient's pelvic area, at the vaginal cuff was an approximately 3cm area of visible mesh, mildly tender to palpation.The specific point of tenderness was over the right side of the pubic bone, an anterior aspect with a small linear mass palpated.A similar underlying structure was palpated over the left pubis but was non-tender.The assessment included mesh exposure, pelvic pain likely related to chronic bladder pain and bladder issues as well as vaginal mesh exposure, vaginal discharge that may represent recurrent bacterial vaginosis (bv), chronic dysuria that needed specialty care given a history of multiple bladder surgeries and interstim, and constipation.On (b)(6) 2021, the patient had an erosion of implanted vaginal mesh and prosthetic materials.She presented with a history of significant pelvic pain for over a few months, probably at least since (b)(6) 2020.She reported significant pelvic pain that was affecting her quality of life.She has been seen by multiple physicians who have told her that she has vaginitis.After voiding, she is in such significant pain that she cannot walk.She does not know how her overactive bladder symptoms have changed since the device was placed, as she has significant pelvic pain affecting her daily quality of life.Of note, she had a hysterectomy in the past, not at the time of the sacral colpopexy.During the review of systems, the patient was positive for dyspareunia, pelvic pain, and vaginal pain.Furthermore, there was mesh erosion observed at the site of the sling and mid-urethra.However, upon the sterile speculum exam (sse), there was almost what appeared to be a dehiscence of the vaginal cuff, where there was a large amount of mesh about 3--4 cm open from the vaginal cuff.Clinical labs and past medical records were reviewed, and chronic illnesses were addressed, including previous sacralcolpopexy and operative records.A comprehensive treatment plan was developed for the new diagnoses of two mesh erosions, and possible dehiscence, including ct, cystoscopy, and plans to proceed to the or within one week.This appointment was scheduled based on the concern that a delay of three months may present an undue risk to the patient's health.On (b)(6) 2021, the patient had two mesh erosions and a concern of possible dehiscence.She presented for a cystoscopy today and discussed proceeding with surgical management as soon as possible.The patient is still positive for dyspareunia, pelvic pain, and vaginal pain.The cystoscopy was performed today with no findings of mesh erosions in the bladder wall.The ct scan will be performed tomorrow to evaluate the bowel and concerns about dehiscence.The patient and the physician discussed in detail that if her symptoms worsen or if there is any concern that her pain is too significant and she cannot wait and this becomes emergent, then the patient will go to the or immediately.However, currently, the earliest non-emergent surgical day is wednesday.On (b)(6) 2021, the patient underwent a revision of the prosthetic vaginal graft by vaginal approach, diagnostic laparascopy, and cystourethroscopy procedure.The patient had a mesh erosion and possible dehiscence.Surgery had been planned for (b)(6) 2021; however, her pain was so severe that she went to the emergency department on (b)(6) 2021, and required emergency surgery.The physician reviewed how the plan was for mesh resection of sacral colpopexy mesh by vaginal approach, repair of vaginal cuff for possible dehiscence, removal of possible mid-urethral sling mesh, possible cystoscopy, possible diagnostic laparoscopy, and any other indicated procedure.A foley catheter was inserted and drained clear urine.A lonestar and stays were used to fully visualize the mesh erosion.It appears that she has a large mesh erosion where the vaginal cuff was fully open, and there was over 4cm of vaginal mesh from the cuff.Dilute vasopressin was injected vaginally around the location of the mesh.Sharp dissection was used to separate the mesh from the anterior and posterior vaginal epithelium.All portions of the ethibond were removed from the edges.Once all the edges of the vaginal epithelium were separated, the mesh eroded from the vagina was fully resected and sent to pathology.The mesh was then resected from the vaginal epithelium.At the time, the tissue edges were debrided, and edges were cut with curved mayo scissors.The vaginal cuff was closed with 2-0 pds in interrupted sutures.The location of the mid-urethral sling was then palpated and there was noted to be no mesh erosion to revise at this time.At this time, a diagnostic laparoscopy was performed.The survey of the upper abdomen was unremarkable.A grasper was then used to move the bowel until it was confirmed that there was no bowel adhered to the cuff/peritoneum.There were no concerns upon visualization of any peritoneum, mesh in the abdominal cavity.A cystoscopy was then performed after the removal of the foley catheter.Four-quadrant inspection of the ladder showed no stones, tumors, or foreign bodies present.Both ureteral orifices were identified and there was good ureteral efflux from both.The cystoscope was removed, and an inspection of the urethra was performed, noting no violation of the tissue.Findings showed large mesh erosion noted from the vaginal cuff with dehiscence, a 6cm vaginal opening with 6cm mesh erosion.A large portion of mesh was resected, and the vaginal cuff was resected from mesh, debrided, and then closed.Diagnostic laparoscopy was performed with abnormal findings, the peritoneum was well closed, and no mesh was observed in the abdominal cavity.Cystoscopy performed with no mesh noted, bilateral ureteral efflux noted.Rectal examination was performed with smooth rectal tone, and no lesions were noted.On (b)(6) 2021, the patient was status post mesh excision, vaginal cuff closure, and diagnostic laparoscopy for vaginal cuff dehiscence, post-operative day 7.Before the surgery, she could not walk or eat due to such significant pain and had to go to the er.Now, she can walk, and the pain has significantly improved.However, over the past several days, her pain has been worsening.The patient reported running out of percocet this morning and stated that her surgeon was in a refill.However, she never did.The patient mentioned that she had lower abdominal/suprapubic pain today.She also has vaginal cuff tenderness and some pain that has radiated near her clitoris, which is new.She denies vaginal discharge, or bleeding.She denied any nausea, vomiting, fever, chills, chest pain, shortness of breath, headache, or dizziness.She is tolerating a regular diet and using pain medications currently.During the physical exam, a sterile speculum exam (sse) was performed on the vaginal cuff intact.Sutures were in place on the cuff and healing well.Some pain upon palpation of the clitoris, but no radiation of pain from the abdomen.Vulvar pain appeared to be related to palpation of the cuff.On (b)(6) 2021, the patient phone-called the physician regarding the pain she experienced.Upon discussion, the patient was initially very happy today as her pain had finally disappeared, and she felt normal again.Therefore, she elected to dance today.However, it appeared that she aggravated her incisional site.She is currently in pain after dancing.The physician told the patient to come to the clinic to further evaluate her.However, she declined this.She is currently using a heating pad.The patient called because she only has one pain medication and has pain again.Some more percocet pills were ordered for her.The physician reviewed how she couldn't come into the clinic over the weekend.She was eating, and ambulating.Her urinary incontinence had improved, and she decreased, and she's decreased her interstim.Overall, she is significantly better from the surgery.The patient's post-operative precautions were reviewed.She will return to the clinic next week unless she needs to be evaluated earlier.On (b)(6) 2021, the patient was checked and had recent prescriptions.Ct imaging was reviewed, and no visible postoperative complications.The patient reported recent bladder surgery and dense fecal retention without mechanical obstruction.There was no free air, free fluid, or abscess.A pelvic exam was performed, and no obvious complications or lesions were noted.It was a normal external exam.On (b)(6) 2021, the patient had a pudendal nerve injection for treating levator spasms and pudendal neuralgia bilaterally.After obtaining consent, the patient was positioned in lithotomy.The patient was assessed and prepared by the nursing staff per protocol.The right ischial spine was identified.Using the pudendal trumpet, 9cc of marcaine (0.25%) and 1cc of kenalog were injected 1cm medial and cephalad to the ischial spine.The same steps were completed on the left.The patient tolerated the procedure well.The vagina was noted to be hemostatic at the end of the procedure, and the patient's post-void residual volume (pvr) was 0cc.Reportedly, this appointment was scheduled based on the concern that a delay of three months may present an undue risk to the patient's health.On (b)(6) 2021, the patient had a follow-up colonoscopy for a history of proctitis but no documentation of such, a history of hematochezia, and finally, a long history of irritable bowel syndrome, initially predominant constipation.Colonoscopy was done given the history of proctitis without documentation that the examination was performed by this examiner and has had no evidence of proctitis since the exam.Constipation, in addition to irritable bowel syndrome, clearly was a problem with multiple analgesics for chronic pain.Since his surgery in january, she has stopped all opioid medication and has a much easier time with bowel function.She also noted that she has both rectal spasms and vaginal spasms.She claimed vaginal spasms on her mesh.On (b)(6) 2021, the patient presented with abdominal pain.Roughly 6 months ago, the patient had a prolapsed bladder with mesh placed in, wherein the first surgery was faulty, and then a second mesh was implanted, but some mesh may have been embedded.A month ago, the patient began having vaginal and abdominal pain.Unable to get into pcp, she has been self-medicating and ran out of medicine the last pm.Today, the patient felt intolerable pain and has not been reassessed.The patient presented to the emergency department with abdominal pain that had been worsening for a week.The patient had mesh placed for a prolapsed bladder about a year ago and is supposed to see a specialist in arizona.She stated there was a complication in that part of the mesh where it had been causing pressure.The pain was described as being sharp over her bladder, into her groin, and down the back of her right leg, and having no modifying factors.She also reported vomiting, decreased appetite for 1 week, and burning chest pain.Per ems, she was self-medicating and ran out of pain medications yesterday.The patient was uncooperative with history.During the physical examination, there was tenderness in the abdominal area, specifically the suprapubic area.The patient attempted to see her ob/gyn but was unable to get an appointment on the same day.She had advised her to go to the emergency room because of the severity of her pain.The patient has been taking her mother's oxycodone for pain control.Furthermore, the patient's differential diagnosis includes but is not limited to vaginitis, pelvic inflammatory disease, neuralgia, chronic pain, abscess, and urinary tract infection.We will perform a 12 exam for further evaluation for possible missed complication vaginitis or concerns for pelvic inflammatory disease.We have also ordered labs, although most of her labs have already been completed, including the cbc bmp urinalysis and urine drug screen.The physician has also ordered a pelvic ultrasound as well as a ct scan to further evaluate for other abscesses or complications that may be contributing to the patient's pain and discomfort today.The patient was asking that we remove her mesh; the physician informed her that he was not able to do this, and it does sound like her ob/gyn wanted her to see a specialist.The patient stated that she was set up to see an out-of-state specialist in august but felt that she needed to be seen sooner by a specialist.The physician has informed her that after her results are back, we will speak with her ob/gyn for further recommendations.The patient was initially given a dose of morphine and zofran and continues complaining of pain; however, her speech was slightly slurred, she was somewhat difficult to get a history from, and the physician does not believe that further narcotics would be appropriate.We will avoid narcotics moving forward and attempt to use gabapentin and toradol for pain control.The patient's labs and imaging studies have been reassuringly negative (ct, ultrasound, and labs) without any concerning findings currently.It is noted that the patient's urinalysis is positive for benzos, and the physician believes that this is the likely cause of her slurred speech.The patient does appear to be sleepy and quickly falls back asleep after waking up and complaining of pain.The patient does have benzodiazepine in her urine, and the physician questioned whether the patient may have taken some of this medication prior to her arrival in the emergency department.However, a head ct was performed, as well as an add-on alcohol level to further rule out life-threatening causes of her slurred speech and sleepiness at this time.The physician will speak with the ob/gyn in case of any further recommendations.The patient's head ct was negative; her alcohol level was noted to be 11.This may have contributed to her slurred speech earlier on repeat evaluation and review of all lab and imaging studies.The patient appeared much more awake and appropriate, with improved speech.The patient stated that she was feeling very weak because she had not been eating for the past several days.She was provided with food, attempted to road test, and was medically believed to be appropriate for discharge home.At this time, there was no evidence of emergent, life-threatening medical problems in her lab or imaging studies, which have been extensive.The patient is aware of this plan of care for potential discharge home with outpatient gabapentin and zofran and follow-up with referrals from her ob/gyn to another physician.The patient has been road-tested, tolerated oral intake, and was able to ambulate.At this point, the patient is appropriate to be discharged home.On (b)(6) 2021, the patient presented with pain.She could not get off the ground and her legs were weak.She was in so much pain, and could not walk, and her mom was helping her to and from the bathroom.The patient was delirious, so she had to go to the er by ambulance.The patient admitted that she was not eating for several days prior.She tried to eat but she vomited each time.Her neighbor carried her upstairs, and something popped into her right rib area, and she did not bend or twist or sit up.She could not get on a bus to arizona.The patient's family looked up arizona gynecology and it had a lot of botched surgeries and lawsuits.So, the patient is not going to go.The patient's mother was giving her medications, and the patient did not know they were hers.As per er, the patient has been taking her mother's oxycodone for pain control.Er ct head and pelvis were reviewed, and no acute findings were found.Additionally, the patient's lumbar radiculopathy and rib pain on the right side were addressed with an x-ray right rib (2 views) and ambulatory referral to physical therapy.On (b)(6) 2021, the patient reported her history of mesh erosion and complained of chronic abdominal pain not improving.She stated that she was out of her pain medication for chronic back pain, also, with complaints of dry heaving, vomiting, and constipation.The patient was not able to have bowel movements in 2 weeks.The patient had a past medical history of any intra-abdominal mesh placement and reported that she thinks this intra-abdominal mesh was coming out of her vagina, and she was complaining of abdominal pain.The patient did run out of her pain medication a couple of weeks ago and has been unsure when she can ask for more pain medication.She came and asked for pain medication today.The patient stated that her pain wasn't being helped by the medications.However, during the interview, the patient was lethargic and seemed slightly obtunded.They hesitated to give the patient narcotics and ketorolac because she had a pending workup.On (b)(6) 2021, the patient presented with pelvic pain.The onset was chronic.The course/duration of symptoms was worsening.Location: pelvis.Radiating pain: none.The character of symptoms was sharp.The degree at present is moderate.There were exacerbating factors, including movement, standing, walking, urination, and defecation.The relieving factor remained still.Risk factors include multiple previous pelvic surgeries, including tah and bladder mesh placement for prolapse.Prior episodes: chronic.Therapy today: none.Associated symptoms: none.The patient reported pelvic pain and was worried that the mesh was tearing through the labia, which had happened previously when she had her mesh revision done.She had dysuria and constipation with no bowel movements for 3 weeks because she was afraid to push because of her pain.The patient also experienced hand numbness which happened for 3 days.She awoke with severe pain in her hands and hand numbness.She had decreased range of motion in her hands.She was told that she had slurred her speech.During the review of systems, it was observed that the patient had weakness, fatigue, decreased activity, burns, dysuria, muscle pain, and joint pain.The patient's differential diagnoses were pelvic pain, urinary tract infection, and pelvic inflammatory disease, not uterine fibroid.On (b)(6) 2021, the patient had a reexamination and was discussed about discharge.She was given with gynecologist's recommendations for outpatient follow-up and the patient's ability to void successfully.She was uncomfortable with this plan because she has been unable to walk on her own for the last week due to pain in her groin with walking.Her nurse noted that she was able to transfer from the wheelchair to bed easily and could stand initially but then slowly slides down the ground.She also has trouble using her hands with pain and trouble gripping.On exam, she had fairly normal strength of her legs, considering how thin she was, as well as positive tinel's tests bilaterally.Per ct imaging, no acute spinal emergency, but the patient was very constipated.On (b)(6) 2021, the patient presented to the emergency department for pelvic/abdominal pain, and constipation that acutely worsening for the past week.She said that she has had this pain since (b)(6) 2021 and believed it was related to a mesh revision surgery in (b)(6) 2021, and she also said that the pain had gotten significantly worse over the past week to the point where she could no longer walk.She said that the pain was somewhat relieved with her oxycodone and medical marijuana and was worsened by movement or engagement of abdominal muscles.She also has been constipated for about 3 weeks and she believed this was due to pain preventing her from bearing down and possibly chronic opioid use.During the review of the systems, it was observed that the patient was positive for nausea and vomiting.During her physical exam, the patient's abdomen was firm, distended, and diffusely tender to palpation but worse in lower quadrants bilaterally.On (b)(6) 2021, the patient presented with weakness.The onset was 5 hours ago.The course/duration of her symptoms was improving.The character of the symptoms was weakness.The degree at present is minimal.On (b)(6) 2022, the patient had difficulty urinating.The patient recently had mesh surgery for a prolapse.The patient presented to the emergency department via ems from home for worsening discomfort and concern that she had complications with her surgery.The patient stated that over the past few months, she had had chronic pain associated with her prior vaginal prolapse surgery.The patient stated that she specifically is not having dysuria or a change in urinary frequency, but with urination, she will sometimes feel like her uterus is falling out abnormally.She states that over the past few days, she has had persistent discomfort, and while in the shower, she thought she felt something abnormal.She got out, used a mirror to check herself, and thought that she could see "all the way up into my abdomen," and this concerned her.She stated that this caused her to come in today to be evaluated.She was concerned that she had an abnormality where something had possibly torn or ripped, allowing her to have a hole in her abdomen.Otherwise, she stated that she had not had any new fevers or chills.The patient stated that she had no other associated symptoms.External exam reveals no lacerations, lesions, ulcers, or significant lymphadenopathy.A speculum exam reveals no active bleeding or discharge is noted.The patient does have a vaginal vault without prolapsed material.Os is healthy and pink.No other discharge or sores were noted.The patient did have discomfort with the speculum exam and placement, but otherwise, this was not severe, and the exam did not have to be terminated early.The patient was advised that there was no evidence of significant prolapse or injury.On (b)(6) 2022, the patient with a history of severe anxiety, ptsd, bipolar, and opiate dependency, seen with previous episodes of hypotension due to narcotics/benzodiazepine overuse, presented for evaluation of her intermittent episodes of weakness.History was obtained from the patient, and a review of her previous medical records at the (b)(6) hospital.She had previously been seen by neurology at unmh for symptoms that were thought to be concerning for tia.However, she had a work-up in the past, which did not show any evidence of stroke or vascular disease.It was thought that she had a functional neurological disorder.She complained of chronic left-sided groin pain.She had a history of bladder prolapse with failure of her mesh requiring removal and repair.She was followed by urology and pain management.She noted that gabapentin in the past was not effective, and she was allergic to lyrica.She had been diagnosed as having pudendal neuralgia.She also had lumbar degenerative disc disease with chronic low back pain.She recently had radiofrequency ablation and complained of weakness and tingling in her feet.She suffered from chronic intractable migraine headaches.She had headaches occurring more than 15 days out of the month, lasting the majority of the day.She is currently on her medication which has mildly reduced her headaches.Her headaches were predominantly several in location, throbbing in quality, associated with photophobia, phonophobia, nausea, and vomiting with dizziness.She did not have any medication overuse.On (b)(6) 2022, the patient presented for evaluation of pelvic pain and urinary symptoms.The patient had robotic-assisted laparoscopic sacrocolpopexy in 2019.Three months after sacrocolpopexy, she started to have pelvic pain and mesh exposure, so she was seen by another physician and underwent vaginal mesh removal.However, she continued to have pain.Also, there were no recurrent pop symptoms.Her main complaint was pelvic pain, and she does have urgency and frequency.She complains of frequency of 8 to 10 per day, nocturia once to twice per night, hesitancy, dysuria, and sometimes symptoms of incomplete emptying.She drinks 2 liters of water per day without consuming coffee.The patient does think she leaks both with coughing and sneezing and with urgency.She cannot quantify.Also, the patient wears pads daily.Furthermore, pain gets worse with exercise and gets better with rest and vaginal lidocaine.She also complains of pain in the external genitalia, which is getting worse with palpation.She was seen by the pain team and failed an injection to the trigger points.The patient reports night sweats currently.Status post hysterectomy, she has not had intercourse for 5 years, but she would like to be sexually active in the future and has no postmenopausal bleeding.The patient had circumferential pain and tenderness at the vaginal introitus, the proximal anterior vaginal wall, and the right obturator area.There was no mesh exposure and no pop.However, the physician was able to feel the mesh at the very proximal part of the vagina, but there was no exposure.Additionally, the sling was in place and looked fine.On (b)(6) 2022, during the physical exam, the patient's cervix appeared normal without lesions or discharge.There was severe vestibular tenderness on palpation, with pain noted 1cm into the introitus.The bilateral levator ani is noted to be hypercontractile with tenderness on both.Bilateral obturator pain to palpation, with the left side being worse.Pain is mostly located on the left vaginal side wall.The pain that the patient was having is similar to the pain she gets during those episodes.Discussed with the patient that there was no evidence of mesh noted in the vagina from the sacral colpopexy.The patient knew that her pelvic pain was multifactorial and that removing the mesh alone might not relieve her pain completely.They will move forward with mesh removal.Before proceeding with the surgery, the patient will be set up for cystoscopy and uds in the office to determine if she will need the sling removed during the case as well.Furthermore, the physician and the patient discussed other causes of pelvic pain, including vulvar pain and the pelvic floor muscles being too contractile and not relaxing as much due to recent surgeries and her history.Vaginal lidocaine cream and gel seem to alleviate pain, and they should continue for external genitalia and introitus pain.Management options were discussed with the patient, with the biggest option that will help with multifactorial pelvic pain being pfpt.And we can start that before or after her surgery.Medications were also discussed, including vaginal valium, abn compound cream, amitriptyline, gabapentin, and nerve injections.The patient has tried tpi in the past with no relief.On (b)(6) 2023, the patient had a past medical history of chronic lower back pain, mixed urinary incontinence, status post-mid-urethral sling surgery, interstim, status post sacrocolpopexy with chronic pelvic pain (cpp), pelvic floor myalgia, vulvodynia, presented for urodynamic studies (uds) and cystoscopy.At the last clinic visit, the patient strongly desired the removal of the mesh.She continued to have ongoing pelvic pain in her groin but now felt like it was worsening down to the level of her thigh.She also reported that she had leakage, but it was unclear if it was due to urgency, as she felt like her cpp made it difficult for her to tell.The physician discussed with the patient that there was no evidence of mesh noted in the bladder from the previous mid-urethral sling.Her pain was reviewed, and it was concluded to be multifactorial, and removing the mesh alone might not relieve her pain completely.The patient was counseled about her high risk of return stress urinary incontinence due to the nature of dissection and the removal of the mesh.Also, the need to perform pfannenstiel was discussed, and an additional 2 lower abdomen incisions in order to have complete removal of sling arms from the fascia.Adhoc changed to include the complete removal of the mid-urethral sling, and the physician will call the patient regarding the surgery date.The patient reported improvement with lidocaine gel.The medical prescription was resent as she was unable to pick it up last week, and she will contact the clinic if she is still unable to obtain it.The patient was offered pudendal nerve blocks again.However, the patient declined as she felt that this did not improve her pain previously.

Manufacturer Narrative

Additional information: b3 (date of event), blocks b5, e1 (healthcare facility address and phone number), and h6 (patient and impact codes) were updated based on the additional information received on july 12, 2023.Block b3 date of event: date of event was approximated to october 04, 2019, the date when the patient first started to experience the symptoms, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The patient's new legal representative is: (b)(6).The implant surgeon is: (b)(6).The revision surgeon is: (b)(6).Other physicians: (b)(6).Block h6: imdrf patient codes: e2006 captures the reportable event of erosion (mesh erosion/intra-abdominal mesh was coming out of her vagina).E2340 captures the reportable event of wound dehiscence (dehiscence of the vaginal cuff).E2330 captures the reportable event of pain (clitoral pain, righ rib pain, pelvic pain, severe pain in her hands, muscle pain, joint pain, chronic left-sided groin pain, chronic lower back pain, vulvodynia, pelvic floor myalgia).E0123 captures the reportable event of nerve damage (levator spasms, pudendal neuralgia, lumbar radiculopathy).E1002 captures the reportable event of abdominal pain.E1309 captures the reportable event of urinary retention (incomplete emptying).E1310 captures the reportable event of infection, urinary tract.E1906 captures the reportable event of unspecified infection (vaginitis).E2326 captures the reportable event of inflammation (proctitis, pelvic inflammatory disease,irritable bowel syndrome).E1405 captures the reportable event of captures the reportable event of dyspareunia.E020201 captures the reportable event of anxiety (severe anxiety).E0206 captures the reportable event of unspecified mental, emotional or behavioural problem (ptsd, bipolar, opiate dependency).Imdrf impact codes: f1905 captures the reportable event of device revision or replacement (mesh requiring removal and repair).F1202 captures the reportable event of disability (she could not walk or eat due to such significant pain).F23 captures the reportable event of unexpected medical intervention (pudendal nerve injections, radiofrequency ablation).F2303 captures the reportable event of medication required (pain medications).F2203 captures the reportable event of imaging required (diagnostic laparoscopy, cystoscopy, pelvic ultrasound and ct scan).

Manufacturer Narrative

Blocks b5, b7 (other relevant history) and h6 (patient and impact codes) were updated based on the additional information received on april 12, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2021, the date of the revision of prosthetic vaginal graft by vaginal approach, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The patient's new legal representative is: atty.(b)(6).Address: (b)(6).Phone number: (b)(6).The implant surgeon is: dr.(b)(6).(b)(6) hospital.(b)(6).(b)(6).The revision surgeon is: dr.(b)(6).(b)(6).(b)(6).Block h6: imdrf patient codes: e2340 captures the reportable event of wound dehiscence (dehiscence of the vaginal cuff).E2330 captures the reportable event of pain (chronic pelvic pain, vulvar pain).E1002 captures the reportable event of abdominal pain.E233001 captures the reportable event of chest pain.E0123 captures the reportable event of nerve damage (for levator spasms and pudendal neuralgia).E1309 captures the reportable event of urinary retention (incomplete emptying)/ e1906 captures the reportable event of unspecified infection (vaginitis).E1405 captures the reportable event of dyspareunia (dyspareunia).Imdrf impact codes: f23 captures the reportable event of unexpected medical intervention (pudendal nerve injections).F2303 captures the reportable event of medication required (pain medications).F2203 captures the reportable event of imaging required (diagnostic laparoscopy, cystoscopy, pelvic ultrasound and ct scan).

Event Description

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Brand Name

OBTRYX II SYSTEM - HALO

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

14675807

MDR Text Key

294779003

Report Number

3005099803-2022-03228

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729837565

UDI-Public

08714729837565

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K121754

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup

Report Date

08/09/2023

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?

Device Operator

Health Professional

Device Expiration Date

11/15/2021

Device Model Number

M0068505110

Device Catalogue Number

850-511

Device Lot Number

0022949684

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Initial Date Manufacturer Received

05/16/2022

Initial Date FDA Received

06/13/2022

Supplement Dates Manufacturer Received

01/17/2023
04/12/2023
07/12/2023

Supplement Dates FDA Received

02/16/2023
05/08/2023
08/09/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

11/16/2018

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Disability; Required Intervention;

Patient Age

45 YR

Patient Sex

Female

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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