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

Model Number M0068502000

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

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 11/16/2011

Event Type  Injury  

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient code e2401 captures the reportable event of unspecified injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a vaginal hysterectomy + anterior and posterior repair + tvt (tension-free vaginal tape) procedure performed on (b)(6) 2011 due to stress urinary incontinence and pelvic organ prolapse.Findings showed grade 2 uterine prolapse, rectocele and cystocele and patent ureters bilaterally after tvt placement.During the implant, there was some bleeding noted from both the ovarian pedicles and interrupted stitches as well as cautery were used.Once hemostasis was assured, the remainder of the pedicles was checked.There was some mild bleeding and interrupted stitches were placed until bleeding was assured.It was difficult to get good hemostasis, hence the more average blood loss with the case.The patient tolerated the procedure well and discharged to par (postanesthesia recovery) in stable condition.Postoperatively, the patient experienced an unknown injury related to the device.

• Brand Name: ADVANTAGE 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: 16972588
• MDR Text Key: 315654721
• Report Number: 3005099803-2023-02598
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• 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: 05/22/2023

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 Expiration Date: 05/31/2014
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00000143
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female