BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502110 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Calcium Deposits/Calcification (1758); Obstruction/Occlusion (2422)
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Event Date 06/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Block b3: the exact event onset date is unknown.The provided event date of (b)(6), 2022, was chosen as a best estimate based on the date of the revision surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of erosion of bladder suspension mesh.Imdrf patient code e230901 captures the reportable event of calcified sling.Imdrf patient code e230901 captures the reportable event of bladder stone.Imdrf impact codes f1905 capture the reportable events of excision of mesh calcification and associated bladder stone.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted during an examination under anesthesia and a tension-free vaginal tape procedure using an advantage kit with cystoscopic guidance.The procedure was performed on (b)(6) 2018, for the treatment of stress urinary incontinence.The patient had a history of stress urinary incontinence following a retropubic mid-urethral sling placement in 2017 and was complicated by mesh erosion at the level of the bladder neck and near the urethral orifices.On (b)(6), 2022, the patient underwent an exploratory laparotomy, transvesical excision of intravesical portion of eroded mid-urethral mesh, excision of mesh calcification and associated bladder stone, bilateral 5f ureteral catheter placement and removal and foley catheter placement (18f latex).The patient tolerated the procedure well with no complications.
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