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 Erosion (1750); Urinary Tract Infection (2120); Hematuria (2558); Fibrosis (3167); Unspecified Tissue Injury (4559)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: exact date unknown.The provided event date was approximated based on the clinic visit in (b)(6) 2022.Block d4, h4: the complainant was unable to provide the suspect device upn and 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 device was implanted at: (b)(6).Block h6: the following imdrh patient codes and impact code capture the reportable events of: e2006- erosion and extrusion.E2313 - fibrosis.E2015 - unspecified tissue injury.E1302 - hematuria.E1310 - urinary tract infection.The following imdrh impact code capture the reportable events of: f1905- device revision or replacement.F1901 - additional surgery.

Event Description

It was reported to boston scientific that an advantage system was implanted into the patient during a total vaginal hysterectomy, bilateral salpingo-oophorectomy, uterosacral ligament suspension, retropubic mid-urethral sling, posterior colporrhaphy, placement and removal of ureteral stents, and cystoscopy procedure performed on (b)(6) 2017, for the treatment of stage iii pelvic organ prolapse and stress urinary incontinence.On (b)(6) 2022, the patient underwent a computerized tomography (ct) scan with a urogram for the evaluation of hematuria and recurring urinary tract infections (utis).The ct was negative for stones and filling anomalies.No cause was identified for the hematuria symptom.A subsequent cystoscopy was attempted; however, the scope was unable to be passed behind the area of the vaginal mesh.Significant mesh erosion was noted into the distal urethra.It was noted that prior to the initial prolapse surgery, the patient had minor stress incontinence; this symptom improved following the implant of the mesh.On (b)(6) 2022, the patient underwent the removal of the vaginal mesh, urethroplasty, and cystoscopy for the treatment of the eroded vaginal mesh, vaginal atrophy and recurrent utis.During the procedure, the mesh was encountered in the distal portion of the urethra, and it was excised sharply with metzenbaum scissors.It was noted that the mesh was going into the urethra; therefore, it was ensured that all the mesh that could be palpated was removed.After this, a repeat cystoscopy was performed, and no further mesh was visualized inside the urethra.The explanted mesh was sent to pathology for analysis.The pathology report noted dense fibrous tissue with response to foreign material.The patient was extubated and then transferred to the post anesthesia care unit (pacu) in stable condition.Note: please note that the exact date of the ct was not mentioned.

Event Description

It was reported to boston scientific that an advantage system was implanted into the patient during a total vaginal hysterectomy, bilateral salpingo-oophorectomy, uterosacral ligament suspension, retropubic mid-urethral sling, posterior colporrhaphy, placement and removal of ureteral stents, and cystoscopy procedure performed on (b)(6) 2017, for the treatment of stage iii pelvic organ prolapse and stress urinary incontinence.On (b)(6) 2022, the patient underwent a computerized tomography (ct) scan with a urogram for the evaluation of hematuria and recurring urinary tract infections (utis).The ct was negative for stones and filling anomalies.No cause was identified for the hematuria symptom.A subsequent cystoscopy was attempted; however, the scope was unable to be passed behind the area of the vaginal mesh.Significant mesh erosion was noted into the distal urethra.It was noted that prior to the initial prolapse surgery, the patient had minor stress incontinence; this symptom improved following the implant of the mesh.On (b)(6) 2022, the patient underwent the removal of the vaginal mesh, urethroplasty, and cystoscopy for the treatment of the eroded vaginal mesh, vaginal atrophy and recurrent utis.During the procedure, the mesh was encountered in the distal portion of the urethra, and it was excised sharply with metzenbaum scissors.It was noted that the mesh was going into the urethra; therefore, it was ensured that all the mesh that could be palpated was removed.After this, a repeat cystoscopy was performed, and no further mesh was visualized inside the urethra.The explanted mesh was sent to pathology for analysis.The pathology report noted dense fibrous tissue with response to foreign material.The patient was extubated and then transferred to the post anesthesia care unit (pacu) in stable condition.Note: please note that the exact date of the ct was not mentioned.

Manufacturer Narrative

Block b3 date of event: exact date unknown.The provided event date was approximated based on the clinic visit in (b)(6) 2022.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Mesh excision surgery at: (b)(6).Block h6: the following imdrh patient codes and impact code capture the reportable events of: e2006- erosion and extrusion, e2313 - fibrosis, e2015 - unspecified tissue injury, e1302 - hematuria, e1310 - urinary tract infection.The following imdrh impact code capture the reportable events of: f1905- device revision or replacement, f1901 - additional surgery.

• 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): 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: 17751092
• MDR Text Key: 323467830
• Report Number: 3005099803-2023-04923
• 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,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2020
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0000063534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female