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

Model Number M0068502110

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Erosion (1750); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Prolapse (2475); Hematuria (2558); Dyspareunia (4505)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2017, the implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The surgeons are: dr.(b)(6).Dr.(b)(6).Revision surgery: surgeon: dr.(b)(6).Assistant: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - erosion e172001 - abscess.E2330 - pain.E1310 - uti.E1310 - vaginal discharge.E1405 - dyspareunia.E1302 - hematuria.E1715 - scar tissue (mucosal ridge).E2340 - dehiscence (lesions along the inferior left aspect of the pelvis).The following imdrf impact codes capture the reportable events of: f1905 - mesh excision.F1901 - urethrocele repair.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a laparoscopic-assisted vaginal hysterectomy + tvt sling procedure performed on (b)(6) 2017, due to stress urinary incontinence.Findings upon cystoscopy found no evidence of an inadvertent injury of the urethra or bladder, but the posterior bladder wall showed submucosal hematoma in the midline in the area of the cervical cuff, which the implant physician believed to be from her hysterectomy.The patient tolerated the procedure well and was taken to the recovery room in stable condition.On (b)(6) 2022, the patient presented with hematuria, pelvic pain, and concern for a uti and ongoing vaginal discharge.Her partner had reported pain with intercourse.The patient had completed imaging studies which showed a 1.8x1.3x2.5cm peripherally enhancing lesions along the inferior left aspect of the pelvis contiguous with the bladder wall though to represent a chronic abscess or fistulous connection with the vagina.A preoperative office exam showed mesh exposure at the mid-urethra with a likely sub-urethral abscess for which she was started on doxycycline.Pelvic exam with patient in lithotomy position revealed mesh exposure at the level of the mid-urethra, 1.5cm distal from urethral meatus.There was a flap of anterior vaginal tissue over the exposure.The underlying dorsal surface of the urethra was epithelialized.On the left aspect of the bladder wall, a mucosal ridge was seen likely consistent with the path of the left arm of the mesh at initial placement.No exposed mesh was seen within this ridge.During the mesh removal, care was taken to cut only the mesh arms which were then removed from the body and sent to pathology.A urethrocele repair was performed by excising the excess vaginal epithelium and reapproximating this tissue with the vaginal incision closure.The patient was then taken to recovery room in stable condition.

• Brand Name: ADVANTAGE FIT 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17744964
• MDR Text Key: 323394406
• Report Number: 3005099803-2023-04933
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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: 09/14/2023

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 Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female