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 Erosion (1750); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Deformity/ Disfigurement (2360); Hematuria (2558); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 06/22/2006

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2006, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) (b)(6) medical center (b)(6).Block h6: imdrf patient codes e2330, e1405, e2401 and e2308 capture the reportable events of pelvic pain; vaginal pain; physical pain and suffering; dyspareunia; other chronic complications of mesh; past and future physical impairment; and past and future disfigurement.

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) 2006.As reported by the patient's attorney, the patient claimed to have suffered pelvic pain, dyspareunia, vaginal pain and other chronic complications of mesh.She also suffered the following damages such as past and future medical and incidental expenses, past and future physical impairment, past and future disfigurement, past and future emotional distress, past and future physical pain and suffering.It was also reported that medical needs of the patient are ongoing.

Manufacturer Narrative

Blocks a1, a4, b2, b5, b6, b7, d6b, e1 below and h6: patient codes and impact codes have been updated based on the additional information received on june 27, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2006, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Assistant: dr.(b)(6).Block h6: imdrf patient codes e2330, e1405, e2401, e2308, e2006, e1309, e2015, e1715, e1301, e2015, e1302, e2326, e1705 and e0506 capture the reportable events of pelvic pain; vaginal pain; physical pain and suffering; dyspareunia; other chronic complications of mesh; past and future physical impairment; and past and future disfigurement, sling erosion, slow stream, atrophy, fornix epithelium, dysuria, leukocytes, urinalysis trace blood, desquamative vaginitis, burning symptoms, and post-menopausal spotting.Imdrf impact code f1903 captures the reportable event of device explantation.

Event Description

It was reported to boston scientific corporation that an obtryx system - curved device was implanted into the patient during a transobturator tape urethral suspension procedure performed on (b)(6) 2006 for the treatment of stress urinary incontinence.The patient was awakened and transferred to the postanesthetic recovery in excellent condition.As reported by the patient's attorney, the patient claimed to have suffered pelvic pain, dyspareunia, vaginal pain and other chronic complications of mesh.She also suffered the following damages such as past and future medical and incidental expenses, past and future physical impairment, past and future disfigurement, past and future emotional distress, past and future physical pain and suffering.It was also reported that medical needs of the patient are ongoing.---additional information received on june 27, 2023--- on (b)(6) 2021, it was reported that the patient had slow stream, positive for hematuria, and utis.There was a right fornix epithelium overlying sling and created band in the right fornix with tender to palpation.Also, possible left fornix erosion and the sling created banding with associated tender to palpation.Possible sling erosion and sling excision was recommended due to dyspareunia.On (b)(6) 2021, the patient reported postmenopausal spotting.She had an endometrial polyp removed via hysteroscopy in 2019.She had normal pelvic ultrasound with endometrial stipe measurement of 4mm at that time.Patient had a urethral sling with mesh that would probably need to be replaced.Physician was not sure if her bleeding was from her urethra or her vagina but could be a combination of both.Spotting was at the middle to front of her pantiliner.Patient was recommended to have a consultation with a urologist.She had vaginal dryness and vaginal estrogen was considered before the procedure.Patient was not sexually active and had dyspareunia with last coitus two years ago.Her discomfort was due to mesh.Physical exam included bladder tenderness under the urethra.On (b)(6) 2021, the patient underwent sling revision and cystoscopy due to dyspareunia and mesh erosion.A mesh erosion was noted in the right fornix.The right and left arms of the mesh were dissected from the surrounding tissue sharply and bluntly then excised as far laterally as possible.The patient was transferred to the post anesthesia care unit in stable condition.On (b)(6) 2022, it was reported that the patient had spotting daily for 2-3 years, discharge but no odor, vaginal dryness, dyspareunia, urethral burning, atrophy, thin over fornix but no overt erosion, dysuria and bladder pain.On (b)(6) 2021, patient had sling revision, cystoscopy and mesh erosion was noted.Spotting was reduced since mesh excision but there was occasional green discharge.The patient had the sensation of something poking on her right side.Urethral pain was resolved.Resolution of discharge on clindamycin though still has some burning symptoms.The urinalysis trace blood, small leukocytes and 7 white blood cells.Assessment or plan: patient had a history of migraines, 1 year status post midurethral sling revision on (b)(6) 2021, recently treated with clindamycin with resolution of discharge.Atrophy was noted on the exam and vulvar and vaginal burning symptoms.Vulvovaginal atrophy: patient tried estrace however this drove recurrence of migraines.It was recommended a trial of vaginal moisturizer for two weeks or imvexxy if no improvement.Vaginal discharge: likely desquamative vaginitis.Had responded to clindamycin daily.Vaginal swab was negative.Intermittent periurethral pain - resolved: this was reported to be likely driven by pelvic floor dysfunction and pelvic floor physical therapy was considered.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16797040
• MDR Text Key: 313842760
• Report Number: 3005099803-2023-02060
• 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
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2009
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0ML6030102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 71 KG