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

Model Number M0068505110

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Urinary Frequency (2275); Discomfort (2330); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2022, initial encounter date, as no event date was reported.Initial reporter: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a transvaginal tape through the obturator, cystoscopy and anterior repair procedures performed on (b)(6) 2015 to treat a patient with stress urinary incontinence and grade 2 cystocele.There were no complications at the conclusion of the procedure.The patient was reversed from anesthesia and taken to the recovery room in stable condition.On (b)(6) 2022, the patient was seen and examined with complaints of dyspareunia.The patient reported pain was on the anterior vaginal wall at the location of the previous sling insertion.She reported that her surgeon cut a piece of exposed sling protruding through the vaginal mucosa in the office several years prior.She has subsequently used three tubes of vaginal estrogen cream without relief.The patient was quite frustrated by this situation.Upon vaginal examination, the anterior vaginal wall, approximately one cm from the urethral meatus, an approximately 1.5 cm firm nodular area was noted.The physician did not note any sling material protruding but the area was very firm and tender.In the physician's' assessment, the patient has dyspareunia, foreign body reaction and complication of implanted vaginal mesh (unspecified complication, sequela).The physician discussed with the patient that he did not note any mesh protruding into the vagina but was still possible.In addition, the physician discussed that this may represent a foreign body reaction with scarring at the mesh site.The physician also discussed with the patient its proximity to the external urethral meatus.It was concluded that the patient needed to be referred to a urogynecology for further evaluation.The patient agreed to the referral at ohio state urogynecology.On (b)(6) 2022, the patient had an erosion of bladder suspension mesh.The patient also experienced leaks that were small and discreet which occurred daily prompting the patient to generally use one pad a day.The symptoms have been stable over the last year.The patient reported urinary frequency, urinary urgency and urge related incontinence.With regard to voiding dysfunction, the patient did not have difficulty starting her stream of urine all of the time.She felt that the flow was continuous and she was able to empty to completion all the time.The patient did not have hematuria, dysuria, kidney stones and recurrent urinary tract infections.She reported nocturia once but had no enuresis.The patient denied a bulge of tissue above the vaginal opening all the time.The patient reported defecatory dysfunction and constipation.On exam, she has exquisite tenderness to either side of the mid urethra in the anterior fornix.There appeared to be a single strand of exposed mesh material just to the right of midline consistent with one area of discomfort.There was also some tensioning in each lateral fornix which may be contributing to her dyspareunia.The physician reviewed this information with her and discussed management strategies including expectant management verses surgical exploration.She has been using topical estrogen without success for a number of years.They discussed the fact that complete removal of the surgical mesh was unlikely to be accomplished and that resection did not guarantee an improvement in her pain.They also discussed the fact that this could substantially alter, and in particular worsen, her present continence profile.She acknowledged these issues and would like to try and resect the exposed mesh and tension line with the goal of improving her dyspareunia.The physician had her sign a consent for this and scheduled her for urethroscopy/cystoscopy pre op.At baseline, the patient has some mixed urinary incontinence complaints.This may or may not change with surgical resection of her mesh.Obviously, if she continued to have incontinence post mesh resection, steps could be taken to address both her urge and stress related complaints.She continued to be a half pack-a-day smoker and has been for close to 40 years.As a result, management of stress incontinence would be restricted to non mesh related interventions moving forward.The patient consented to undergo a removal or revision of vaginal prosthetic graft vaginal approach (midline) and cystourethroscopy diagnostic procedures.Exam under anesthesia noted two sites of sling mesh exposures in bilateral sulci, otherwise the vaginal tissue was noted to be normal.The mesh was dissected and approximately 1.5 cm of mesh was excised from each sulcus.The patient had good hemostasis.There were no complications at the conclusion of the procedure.The patient tolerated the procedure well.Instrument and sponge count was correct x2.

• 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): 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: 15597489
• MDR Text Key: 301669415
• Report Number: 3005099803-2022-05940
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: ML00002978
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female