ADVANTAGE SYSTEM

Additional Manufacturer Narrative

BLOCKS 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. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: BOSTON SCIENTIFIC RECEIVED THIS COMPLAINT FROM A PATIENT VIA AUSTRALIAN REGULATORY AUTHORITY (TGA). DETAILS RELATED TO THE INITIAL REPORTER WERE NOT PROVIDED. BLOCK H6: THE FOLLOWING IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E2006 - EROSION E2328 - OBSTRUCTION E1310 - URINARY TRACT INFECTION THE FOLLOWING IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENTS OF: F12 - SERIOUS INJURY/ILLNESS/IMPAIRMENT BLOCK H11: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED ADVERSE EVENTS OF EROSION, URETHRAL OBSTRUCTION, AND URINARY INFECTION ARE KNOWN RISKS OF THE SURGICAL PROCEDURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED, AND THE REPORTED INCIDENT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE FOR THIS EVENT IS CAUSE NOT ESTABLISHED, WHICH INDICATES THAT THE REPORTED ADVERSE EVENT IS KNOWN AND DOCUMENTED IN THE LABELING (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS). ADDITIONALLY, WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN WHICH CONTRIBUTING FACTORS LED TO THE EVENT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANTAGE SYSTEM WAS IMPLANTED TO THE PATIENT ON (B)(6) 2006. FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED VAGINAL MESH EROSION, URETHRAL OBSTRUCTION, AND RECURRENT URINARY TRACT INFECTIONS, PROMPTING REFERRAL FOR FURTHER EVALUATION. CYSTOSCOPIC EVALUATION IDENTIFIED VAGINAL EROSION OF MESH FROM BOTH SLINGS. FLEXIBLE CYSTOSCOPY PERFORMED IN 2025 DEMONSTRATED A NORMAL BLADDER AND URETHRA WITH NO EVIDENCE OF MALIGNANCY, CYSTITIS, STONES, MESH, OR OTHER SURGICAL FOREIGN BODIES WITHIN THE LOWER URINARY TRACT. FINDINGS WERE CONSISTENT WITH VAGINAL EROSION OF BOTH MIDURETERAL SLINGS EXTENDING FROM THE MID-URETHRA TO THE RIGHT VAGINAL FORNIX.