BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number M0068502000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Vaginal Mucosa Damage (2124)
|
Event Date 09/03/2014 |
Event Type
Injury
|
Manufacturer Narrative
|
Block b3 date of event: date of event was approximated to (b)(6) 2014, the implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Revision surgery: (b)(6) block h6: imdrf patient codes e2006, e1519, e0506 and e230901 capture the reportable events of exposure of mesh within the urethra, anterior vaginal wall polyps, vaginal spotting, and calcification.Imdrf impact codes f1905 and f1901 capture the reportable events of mesh excision and excision of anterior vaginal wall polyps.
|
|
Event Description
|
It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a tvt procedure performed on (b)(4) 2014, for the treatment of stress urinary incontinence.The procedure was completed with no complications.The patient was taken to the recovery room in stable condition.On (b)(6) 2023, the patient presented with bothersome vaginal spotting from a polypoid mass of the vagina.She had to undergo excision of anterior vaginal wall polyps and removal of exposed urethral mesh.Findings showed a polypoid friable soft polyp originating from the anterior mid urethra.There was a dimpling of the vaginal mucosa at this location.Cystoscopy now reveals exposure of mesh within the urethra, and this was partially calcified.During the procedure, an elliptical incision was created sharply around the dimpled portion of the urethra including the polypoid mass.The mass and vaginal mucosa were sent as a specimen.Mesh was excised and sent for specimen.The physician did not continue to work to remove the entire mesh.The patient tolerated the procedure well and there were no complications or implants.
|
|
Search Alerts/Recalls
|
|
|