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

Model Number M0068504001

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

Patient Problems Micturition Urgency (1871); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Frequency (2275); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 12/21/2010

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2010, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Phone number: (b)(6).The revision surgeon is: (b)(6).Other healthcare facility: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx curved system device was implanted during a vaginal hysterectomy with bladder neck suspension with transobturator sling using obtryx with conservative therapy procedure performed on (b)(6) 2010.The patient had abnormal uterine bleeding with failed endometrial ablation and conservative therapy.After the hysterectomy, the patient had a very minimal cystocele but still had a grade i to ii rectocele, which was not symptomatic for the patient, and she proceeded with the tension-free vaginal tape procedure because of the significant incontinence she experienced.Also, a foley catheter was placed in the patient as well as vaginal packing.On (b)(6) 2021, the patient had an office visit (gynecology) and she presented with prolapse.The symptoms began 3 years ago and generally last 3 years.The symptoms were reported as being moderate.The symptoms occur daily, and the location was vaginal.She stated the symptoms were chronic and uncontrolled.The patient reported vaginal pressure and a bulge at the entrance of the vagina.She also reported sometimes having urinary leakage with laughter, cough, or sneeze and with urgency.The leakage with urgency was more troublesome for her.Furthermore, the patient had urinary frequency, feelings of incomplete bladder emptying, and nocturia once to twice a day.The patient is sexually active and experienced dyspareunia deeper in the vagina and with initial penetration.The patient had gastric sleeve surgery in (b)(6) 2021.She had lost 70 pounds since her appointment last year.Her voiding diary showed 10 voids in 24 hours, leakage with urgency.However, urodynamics revealed no retention, no stress, and urgency without leakage.According to the system review, the patient experienced incomplete emptying, nocturia, frequency, prolapsed uterus, stress incontinence, urge incontinence, urgency, urinary frequency, and dyspareunia.Also, the patient had a history of abnormal pap smears, and she was post-menopausal.On (b)(6) 2022, the patient underwent sling revision, urethral lysis, and anterior colporrhaphy removal of mesh from the obturator internus muscle.She experienced vaginal pain, pain with intercourse, foreign material in the vagina and in the pelvic muscles, and urethral scarring.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in the modified dorsal lithotomy position and prepped and draped in the usual manner for abdomino-vaginal surgery.The foley was inserted and noted to be draining clear yellow urine.The anterior vaginal wall was grasped with two allis clamps and opened.The sling mesh, scar tissue, and cystocele were dissected cephalad, caudad, and laterally.A urethral lysis was performed using sharp dissection to further free the scar tissue and the mesh from the urethra.On the right, the dissection identified the mesh trajectory, and an incision was made into the obturator internus muscle and the mesh was removed.The same was done on the contralateral side.The anterior vaginal wall was closed with a running locked layer of #2-0 dexon.The vagina was light packed with iodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The pathological findings from the obtryx vaginal mesh removal procedure showed polarizable synthetic mesh with chronic inflammation and foreign body reaction.On (b)(6) 2022, the patient had a post-operative visit after her sling revision, urethral lysis, and anterior removal of mesh from the obturator internus muscle.The patient is well and has no complaints at that time.However, after some time post-procedure, she had reports of some urinary leakage with urgency.

• Brand Name: OBTRYX SYSTEM
• 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: 15605314
• MDR Text Key: 301731658
• Report Number: 3005099803-2022-05832
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718970
• UDI-Public: 08714729718970
• 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
• Report Date: 10/14/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: M0068504001
• Device Catalogue Number: 850-400
• Device Lot Number: 0ML8100603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female