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

Model Number M0068505000

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

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Insufficient Information (4580)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6), 2021, date when the device was implanted.This event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a obtryx system - halo was implanted on (b)(6), 2021.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, pelvic pain, groin pain, perineal pain, dyspareunia, vaginal pain, urinary issues, erosion inflammation and foreign body reaction as well as the need for surgical revision.The patient claims to have suffered the following damages as a result of the implantation of the obtryx device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted on (b)(6) 2021.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, pelvic pain, groin pain, perineal pain, dyspareunia, vaginal pain, urinary issues, erosion inflammation and foreign body reaction as well as the need for surgical revision.The patient claims to have suffered the following damages as a result of the implantation of the obtryx device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Additional information received on march 10, 2023.The procedure performed on (b)(6) 2021 was obtryx transobturator suburethral sling.The procedure was performed to treat the patient's stress urinary incontinence.There were no patient complications reported at the conclusion of the procedure.On (b)(6) 2022, the patient was seen an examined for complaints of vaginal pain, pelvic pain, pain with coitus, and muscular groin pain.Post operative diagnosis includes vaginal pain, pelvic pain, pain with coitus, muscular groin pain and urethral scarring.The patient underwent a removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, mesh removal from the deep obturator internus muscles, and anterior colporrhaphy.During the procedure, the previous obtryx sling mesh was identified at the bladder neck and carefully freed from the urethral/bladder neck location and the scar tissue, a urethral lysis was performed using sharp dissection to further free the scar tissue.With the vaginal paravaginal spaces opened, further dissection and visualization of the mesh trajectory permitted mobilization of the mesh within the obturator internus muscles, tendons and bone bilaterally.Traction and counter traction identified the fixation point of the mesh on the pubic ramus that was freed from the bone from the vaginal side as well as from the vulvar side and the mesh was fully excised.The entire obtryx mesh was removed.The incisions were closed using sutures and the vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.Needle, sponge and instrument count was correct times two.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

Manufacturer Narrative

Block b3: date of event is approximated to december 10, 2021, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(6) medical center.(b)(6).Block h6: patient codes e2006, e1311, e0206, e2330, e0402, e1405 and captures the reportable events of erosion, unspecified kidney or urinary problem, unspecified mental, emotional or behavioral problem, pain and hypersensitivity/allergic reaction, and dyspareunia.Impact codes f12 and f1905 captures the reportable events of serious injury/illness/impairment and need for surgical revision.Block h11: blocks a1, a2, b5, d6b, e1 (initial reporter facility name, initial reporter zip/post code), h6 and h10 have been updated based on the additional information received on march 10, 2023.Block h6: patient code e2006 captures the reportable event of erosion.Patient code e1311 captures the reportable event of unspecified kidney or urinary problemx.Patient code e0206 captures the reportable event of unspecified mental, emotional or behavioral problem.Patient code e2330 captures the reportable event of pain.Patient code e0402 captures the reportable event of allergic reaction.Patient code e1405 captures the reportable event of dyspareunia, patient code e2326 captures the reportable event of inflammation.Patient code e1715 captures the reportable event of scar tissue.Impact code f1905 captures the reportable event of device revision procedure.Impact code f1903 captures the reportable event of mesh explant.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted into the patient during a posterior repair + total vaginal hysterectomy without bilateral salpingo-oophorectomy + vaginal vault suspension procedure performed on (b)(6) 2021 for the treatment of stress urinary incontinence.There were no patient complications reported at the conclusion of the procedure.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, pelvic pain, groin pain, perineal pain, dyspareunia, vaginal pain, urinary issues, erosion inflammation and foreign body reaction as well as the need for surgical revision.The patient claims to have suffered the following damages as a result of the implantation of the obtryx device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.In an office consultation on (b)(6) 2022, she states she is now 12 weeks out of surgery and claims the pain is worse.She states she also has pressure inside the vagina.She has multiple pain and states her: #1 point of pain is in the groin with r> l, #2 pain - heaviness inside the vagina.Groin pain (0-10) rest - right 0/10 left 0/10; activity right 6/10 and left side 4/1 o; intercourse - nia; vaginal pain at rest - 0/10, activity 8/10, with intercourse 4/10 achy pain.Before the sling her sexual encounters were 3-4 x per week and at 6 weeks, she was having sex every other day and now at 12 weeks she is having sex 2x per week because pain has become worse.She states the sling has stopped her sui (with sneeze, cough, vomiting and no episodes) and she still has frequency, urgency every 30 minutes and at nighttime 1-2 times per night.In a phone conversation in february 2022, she stated pain was getting gradually better.She thought at this point she would not have pain as she is not excessively active.She has attempted intercourse and claims the pain is at insertion.She states at 6 weeks the pain was better at 6 weeks and the pain is worse during intercourse at 9 weeks.She had post op follow-up at 6 weeks with a gynecologist and stated support was good and everything looked fine.She has not discussed this with her gyn.She had sex at 6-7 weeks and the pain was not as bad.But now the pain is not tolerable.She has engaged in intercourse since phone discussion.It was also reported that patient is having very achy legs, pelvic heaviness, and occasional sharp odd pain in her groin at her sling scars.She suffered from leg pain and pelvic heaviness before her surgery but thought it was prolapse related.At his point, 9 weeks post-surgery, she thought the aching would be better.She also claimed to have tailbone pain and frequent urination.In an office visit on march 9, 2022, it was reported that the patient was amenorrheic due to hysterectomy.She had hysterectomy without removal of ovaries.She was self-referred for a small sized lesion location on the vulva.It was described as tender.She reported vulvar discomfort and vulvar pain.She also reported that sitting, trauma, wiping, and using the bathroom aggravated her symptoms.The patient did not have a prior history of this condition.She stated that nothing relieves the pain.The patient had a posterior repair, total vaginal hysterectomy without bilateral salpingo-oophorectomy, and vaginal vault suspension surgery on december 10, 2021.Since then, she had pelvic pressure, heaviness and pain that radiated to her thighs that has been ongoing for past two months.She visited the office for the complaints of sharp, shooting pain and irritation localized to small area to the right of her urethra that was a new onset over the past two days.She wanted a consultation regarding a possible removal of mesh.This was pursued due to chronic pain worsening with standing or walking.The patient noted mild tenderness on exam with palpation of the sub urethral area.No specific abnormalities found, and no exposed mesh was noted.It was reported during a visit on may 19, 2022, that the symptoms began six months ago and generally lasted for six months.The symptoms are reported as being moderate.The symptoms occur constantly.The location is vagina, groins.Aggravating factors include sitting position, standing, walking.Relieving factors include rest.She states the symptoms are chronic.Patient had a tvh, bs, 55 lf, and tot obtryx sling placement in (b)(6) 2021.Since placement she has had bilateral groin pain.She reports dyspareunia with penetration and deep thrusting.She is undergoing pelvic floor pt which has somewhat helped.She denies urinary incontinence with laughing/coughing/sneezing but does report frequency and urgency.She reports incomplete bladder emptying.Denies bowel concerns.Review of system: nocturia urinary urgency urinary frequency anxiety back pain, joint pain dyspareunia on june 7, 2022, the patient had a physical therapy appointment and reported increased pelvic pain and dyspareunia since she had prolapse repair, hysterectomy and bladder sling in december.Pain was in her groin and pubic bone now with episodes that go down her legs.It ranges from 1-7/10 and worsened with exercise, going to the store, hiking, walking, sex, pelvic exams, and for no apparent reason.She still noticed pressure in her pelvis when standing, but she was no longer waking up with that complaint.She was voiding every 45 minutes and felt like she would lose urine if she did not go to the bathroom when she felt the urge.Bowel movements had been difficult this week with diet changes with taking steroids for covid and she thought this was part of the change.She had resumed colace.Pelvic floor internal exam included palpation anterior pelvic floor around sling.She was sore after visit for the rest of the day.She noticed a sharp pain on her right side near her underwear line.On (b)(6) 2022, the patient was seen an examined for complaints of vaginal pain, pelvic pain, pain with coitus, and muscular groin pain.Post operative diagnosis includes vaginal pain, pelvic pain, pain with coitus, muscular groin pain and urethral scarring.The patient underwent a removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, mesh removal from the deep obturator internus muscles, and anterior colporrhaphy.During the procedure, the previous obtryx sling mesh was identified at the bladder neck and carefully freed from the urethral/bladder neck location and the scar tissue, a urethral lysis was performed using sharp dissection to further free the scar tissue.With the vaginal paravaginal spaces opened, further dissection and visualization of the mesh trajectory permitted mobilization of the mesh within the obturator internus muscles, tendons and bone bilaterally.Traction and counter traction identified the fixation point of the mesh on the pubic ramus that was freed from the bone from the vaginal side as well as from the vulvar side and the mesh was fully excised.The entire obtryx mesh was removed.The incisions were closed using sutures and the vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.Needle, sponge and instrument count was correct times two.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.Pathology result included benign fibroadipose tissue with foreign body giant cell reaction to polarizable foreign material consistent with mesh.Gross description stated an obtryx was a 24.2 x 0.9 x 0.2 cm segment of white, clear mesh with adherent pink-tan fibrous tissue.Another pt appointment on septem(b)(6) 2022, patient reports she had her mesh sling removed on july 22nd.About one week later, she bent forward while helping her son, and her back locked up.Since then, she has had pain when bending forward, performing a large amount of household duties, standing for a longer period of time, and driving; the pain is greater on her right side.She also reports her pelvic floor is tight and she wants to get it looked at.She has a past history of lbp with herniated discs in her l/s.

Manufacturer Narrative

Blocks a6, b5, b6, b7, and h6: patient codes and impact codes have been updated based on the additional information received on august 2, 2023.Block a4: the patient's weight ranged from 185 lbs.On (b)(6) 2022 down to 177 lbs.On (b)(6) 2022.Block b3: date of event is approximated to (b)(6) 2021, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.Garrett lischer parkwest medical center united states block h6: imdrf patient codes e2006, e1311, e0206, e2330, e0402, e1405, e2326, e1715, e1309, e2101, e2401, e2340 and e2311 capture the reportable events of erosion, unspecified kidney or urinary problem, unspecified mental, emotional or behavioral problem, pain, hypersensitivity/allergic reaction, dyspareunia, inflammation, scar tissue, incomplete bladder emptying, adhesion, amenorrheic, and small sized lesion location on the vulva.Imdrf impact codes f12, f1905 and f1903 capture the reportable events of serious injury/illness/impairment, need for surgical revision and mesh explantation.

• Brand Name: OBTRYX 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: 16096788
• MDR Text Key: 306637687
• Report Number: 3005099803-2022-07960
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0028284469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White