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

Model Number M0068504000

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

Patient Problems Abdominal Pain (1685); Calcium Deposits/Calcification (1758); Dyspnea (1816); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Deformity/ Disfigurement (2360); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); Fibrosis (3167); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6), (b)(6) hospital, (b)(6) tennessee.Block h6: imdrf patient codes e0206.E1906, e1413, e1311, e2330, e2326, e2015, and e2401 capture the reportable events of urinary retention; pain; infection; inflammation; sexual dysfunction; tissue damage; mental, emotional or behavioral problem, and physical injury and deformity.Impact codes f1903, f1202, and f2303, capture the reportable event of device explantation, disability and medication required.

Event Description

It was reported to boston scientific corporation that an obtryx system- curved device was implanted into the patient during a procedure performed on (b)(6) 2019.The patient has suffered the following injuries as a result of the implant: pain, inflammation, infection, sexual dysfunction, vaginal tissue injury, urinary dysfunction, surgery for mesh removal and emotional and mental anguish.Additionally, the patient has suffered the following damages: physical injury and deformity; physical disability, future medical care and treatment, medical expenses and future out of pocket expenses and loss of income.

Manufacturer Narrative

Blocks a1, a2, b2, b5, e1 below, and h6: patient codes and impact codes have been updated based on the additional information received on august 30, 2023.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as a best estimate based on the date the mesh was partially removed.Block e1: this event was reported by the patient's legal representation.Implant surgeons are: dr.(b)(6).Mesh removal surgeons are: surgeon: dr.(b)(6).Assistant: dr.(b)(6).Block h6: imdrf patient code e1311 captures the reportable event of urinary problem.Imdrf patient code e0206 captures the reportable event of mental, emotional or behavioral problem.Imdrf patient code e1906 captures the reportable event of infection.Imdrf patient code e1413 captures the reportable event of sexual dysfunction.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2326 captures the reportable event of inflammation.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e2015 captures the reportable event of vaginal tissue damage.Imdrf patient code e2401 captures the reportable event of physical injury and deformity.Imdrf impact code f1905 captures the reportable event of partial removal of the sling.Imdrf impact code f1202 captures the reportable event of medication required.Imdrf impact code f2303 captures the reportable event of physical disability.

Event Description

It was reported to boston scientific corporation that an obtryx system - curved device was implanted into the patient during a robot - assisted total laparoscopic hysterectomy, bilateral salpingectomy, tap block, cystoscopy, and transobutrator sling procedure performed on (b)(6) 2019, for the treatment of stress incontinence, abnormal uterine bleeding and dysmenorrhea.The procedure was completed with no complications.The patient was awakened and taken to recovery in good condition.The patient has suffered the following injuries as a result of the implant: pain, inflammation, infection, sexual dysfunction, vaginal tissue injury, urinary dysfunction, surgery for mesh removal and emotional and mental anguish.Additionally, the patient has suffered the following damages: physical injury and deformity; physical disability, future medical care and treatment, medical expenses, and future out of pocket expenses and loss of income.On (b)(6) 2022, the patient underwent partial removal of the mid-urethral sling and cystoscopy due to a diagnosis of vaginal pain, dyspareunia, leg, and groin pain.Findings showed no foreign bodies, injury, or pathology in bladder or urethra as well as bilateral ureteral jets at completion of procedure.During the removal surgery, the right and left portions of the sling were isolated and dissected out to the obturator foramen.The mesh was then sent to pathology for gross evaluation.At the end of the procedure, the patient was accompanied to the recovery room in good condition after extubation.

Event Description

It was reported to boston scientific corporation that an obtryx system - curved device was implanted into the patient during a robot - assisted total laparoscopic hysterectomy, bilateral salpingectomy, tap block, cystoscopy, and transobutrator sling procedure performed on (b)(6) 2019, for the treatment of stress incontinence, abnormal uterine bleeding and dysmenorrhea.The procedure was completed with no complications.The patient was awakened and taken to recovery in good condition.The patient has suffered the following injuries as a result of the implant: pain, inflammation, infection, sexual dysfunction, vaginal tissue injury, urinary dysfunction, surgery for mesh removal and emotional and mental anguish.Additionally, the patient has suffered the following damages: physical injury and deformity; physical disability, future medical care and treatment, medical expenses, and future out of pocket expenses and loss of income.On (b)(6) 2022, the patient underwent partial removal of the mid-urethral sling and cystoscopy due to a diagnosis of vaginal pain, dyspareunia, leg, and groin pain.Findings showed no foreign bodies, injury, or pathology in bladder or urethra as well as bilateral ureteral jets at completion of procedure.During the removal surgery, the right and left portions of the sling were isolated and dissected out to the obturator foramen.The mesh was then sent to pathology for gross evaluation.At the end of the procedure, the patient was accompanied to the recovery room in good condition after extubation.Additional information received on october 10, 2023.In an office visit of (b)(6) 2019, patient reported frequent yeast infections since (transobturator tape) tot sling placement.The patient had taken diflucan along with her prescribed antibiotics prior to the appointment.The patient alleged burning and irritation with intercourse and continued stress urinary incontinence (sui).Additionally, the patient alleged having experienced consistent pubic pain since the tot placement but with new complaints of unexplained left lower quadrant abdominal pain.The pain was unexplained by computed tomography (ct) scan other than an incidental finding of right ovarian vein thrombosis; however, it was noted that this is not uncommon finding and is unlikely to be the source of her abdominal pain.Although extensive reassurance was provided regarding the thrombosis and its likely benign nature, the patient continued to be concerned about chance of a pulmonary embolism.The pain was suspected to be of gastrointestinal (gi) etiology, the patient was scheduled to see a specialist.Transvaginal ultrasound in clinic was also ordered to evaluate for possibly gyn pathology causing her abdominal pain.Patient reports that she was seen at the emergency room on (b)(6) 2019 for severe left lower quadrant abdominal pain.She received a gl cocktail and a ct abdomen/pelvis and was deemed stable for discharge and sent home.The following day, she saw her primary care physician and sent to (b)(6) for lab work based on the ct read describing a non-occluding thrombus in her right ovarian vein.D-dimer was elevated at this time, so she was sent immediately to where she received a chest and abdominal x-ray was told that she had calcifications in her gallbladder, pelvic vasculature, and kidneys.The er advised to be evaluated immediately for these complaints, so the patient made follow up appointments with gyn and gl.In a similar timeframe, she had a large gush of urine on (b)(6) 2019.The patient indicates that she has never been happy with her sling and has had pubic pain since the procedure.She has continued to have symptoms of stress urinary incontinence since her sling was inserted.During the review of systems, shortness of breath, abdominal pain and pelvic pain were noted.On (b)(6) 2019, the patient came to visit complaining of chronic postoperative pain.She has had pain since hysterectomy that was done for pelvic pain and painful intercourse.The pain is constant.She does leak with cough, laugh, sneeze, etc.She is taking tylenol.She has taken dilauded for rheum and it helps a little.She also has urgency, frequency, and leaking with urgency.Pain is sharp before she urinates, she still has pain after she urinates.She stated the pain is located over her bladder area.Her pain was present prior to surgery, but worse after the sling placement.She is not emptying her bladder well.She has rheumatoid arthritis.Had transvaginal ultrasound without worrisome findings.She states that she has a sensation of something dropping.She had laparoscopic surgery for left ovarian mass that was benign but in 2017, she had recurrent left ovarian mass.During the review of systems, the patient was positive for frequency, pelvic pain, urgency, and vaginal pain.Genitourinary comments stated exquisite tenderness on left and right levators and obturator.Left greater than right.Pain on palpation of bladder and urethra.The patient was not able to tolerate the completion of the exam to complete a bimanual, as she was tearful and in pain.The patient underwent a transvaginal ultrasound (b)(6) 2019 identifying uterus was surgically absent, and the bladder sling was in place.Bilateral ovaries with multiple sub-centimeter cysts seen.Blood flow seen and dopplered in bilateral ovaries.The ovaries do not appear mobile when abdominal pressure is applied although this technique was difficult due to patient's pain tolerance.The left ovary was difficult to fully evaluate due to bowel shadowing.Small amount of free fluid seen in the right adnexa measuring 2.2 x 1.6 cm, the patient expressed pain throughout the transvaginal ultrasound, excess bowel shadowing and parous also seen throughout pelvis.The ct of the abdomen pelvis on (b)(6) 2019, was compared with a previous scan performed on (b)(6) 2014.During this comparison it was noted that there was trace physiologic free fluid on the peritoneum.There were few hypoattenuating lesions measuring up to 8 mm in the liver; these, are most likely cysts.The uterus was senescent with a right corpus luteal cyst.Additionally, the right ovary had an asymmetric enlargement and there was a nonocclusive thrombus in the right ovarian vein.The overall impression was that there were no findings that explained the left-sided abdominal pain.Although the thrombus was seen, there were no inflammatory changes that suggested thrombophlebitis (2/120) and the asymmetric enlargement of the right ovary with the corpus luteal cyst may be partly secondary, there were no findings that suggested torsion.The assessment/plan was developed according to the patient symptoms.For the pelvic pain, multiple possible etiologies were discussed.The patient had surgery for a left ovarian mass that was benign in 2013 and recently had a surgery with for laparoscopic hysterectomy and tot placement in (b)(6) 2019; however, no mention of the ovaries was made in the operative note.The recent transvaginal ultrasound and ct of the abdomen and pelvis did not identify any worrisome findings.The patient indicated the pain can be in her upper abdomen above her umbilicus as well as left and right lower quadrants to over her bladder.There were doubts regarding the tot being the source of the pain.It was also noted that the nonocclusive thrombus on the right ovarian vein is unlikely to be causing the pain, as it has been present for years, event prior to the tot implant.Due to the mixed urinary incontinence, pelvic pain, and recurrence of sui, a cystoscopy and exam under anesthesia was recommended.It was discussed that the chronic pelvic pain could be potentially due to interstitial cystitis or some type of myofascial pain syndrome of the pelvic floor.Pelvic floor physical therapy was discussed, which the patient seemed amenable to and would start with it.The patient has celiac disease and notes having a follow up appointment for (b)(6) 2019.Trace blood was seen on urinalysis; therefore, sample would be sent urinalysis with reflex microscopy.The urinalysis noted the patient experienced dysuria.For the mixed urinary incontinence, a treatment of 10 mg of oxybutynin xl would be started.The most common side effects of the medication were reviewed with the patient.Additionally, they discussed the new emerging data on anticholinergics and the patient was informed of the potential risks.It was noted that the pelvic floor therapy could improve her symptoms.It was recommended that the patient does not ingest more than 8 oz of caffeine and 64 oz of total fluid in a day.The patient should not drink any fluids four hours prior to bedtime and void prior to going to bed.In an office visit of (b)(6) 2022, the patient was still having pain before, during, and after urinating and bowel movements.The pain was felt in the vagina, and inside the thighs; however, it radiated to the abdomen, legs, and back.Walking worse.The patient had two sessions of pelvic floor physical therapy, but was not getting any relief; therefore, the sessions were stopped.The patient suspended taking the gabapentin elavil.The patient expressed concern about not being able to sleep and that no medicine that she had tried worked.The patient noted the ativan prescribed on the last visit helped her sleep a little bit.She also alleged the spasms were getting worse.The bowel movements and urination were normal.The patient was still taking miralax and senokot; the patient was advised to stop taking senokot and taking metamucil instead.The patient denied any fevers, chills, nausea or vomiting.Regarding the nerve pain, bladder pain and vaginal pain, there was a long discussion on pain management.The physician advised the sling may be causing the symptoms since the gi work up was negative.The patient had undergone several positron emission tomography (pet) scans; however, there was no intra-abdominal pathology other than some inguinal adenopathy on the left.The patient was advised to not remove the entire sling as it could add more problems.The patient was informed of the risks and benefits and consented to a partial removal and cystoscopy.Regarding the urgency, frequency, and sui symptoms, it was noted that the patient discontinued the use of myrbetriq and oxybutynin.The patient did not desire to restart pelvic floor physical therapy.The patient indicated that although these symptoms were bothersome, she wished to focus on the pain first.It was decided that the symptoms would be readdressed after surgery.On april 18, 2022, pathology received two fragments of irregular, ragged, pale tan-pink fibromembranous tissue.Sectioning demonstrated embedded mesh material.There were no masses or nodules identified.The explained synthetic mesh had associated fibrous tissue.

Manufacturer Narrative

Blocks a4, b5, b7 and h6 patient codes have been updated due to additional information received on october 10, 2023.Block b3: date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.Implant surgeons are: dr.(b)(6).Dr.(b)(6).Mesh removal surgeons are: surgeon: dr.(b)(6).Assistant: dr.(b)(6).(b)(6) hospital.(b)(6).Block h6: the following imdrf patient code capture the reportable events of: e1311 - urinary problem.E0206 - mental, emotional or behavioral problem.E1906 - infection.E1413 - sexual dysfunction.E2330 - pain.E2326 - inflammation.E1405 - dyspareunia.E2015 - vaginal tissue damage.E2401 - physical injury.E2308 - deformity.E1309 - urinary retention.E1002 - abdominal pain.E2313 - fibrosis.E1302 - hematuria.E1605 - spasm.E230901 - calcification.The following imdrf impact code capture the reportable events of: f1905 - partial removal of the sling.F1202 - physical disability.F2303 - medication required.Block 11: h6 patient codes above has been corrected.(e2308 to capture the event of deformity instead of e2401 - physical injury and deformity).

• Brand Name: OBTRYX SYSTEM - CURVED
• 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 ; 5086834015
• MDR Report Key: 17467673
• MDR Text Key: 320472067
• Report Number: 3005099803-2023-04138
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0023298527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 83 KG