BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Ischemia (1942); Hernia (2240); Obstruction/Occlusion (2422); Bowel Perforation (2668)
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Event Date 07/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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This complaint was reported by the patient's lawyer.The device was implanted at (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an advantage system was implanted into the patient during a laparoscopic supracervical hysterectomy with a bilateral salpingectomy, laparoscopic sacrocolpopexy, anterior and posterior colporrhaphy, midurethral retropubic sling and cystoscopy procedure performed on (b)(6) 2016.The patient underwent a revision surgery on (b)(6) 2017 due to abdominal pain.Through hassan technique in the abdomen, an ischemic looking intestine was observed and an internal herniation was found.There were also 3 small perforations noted due to the pressure of the fluid on the bowel.Upon further examination through open procedure, it was found that the mesh was the cause of the obstruction and was stuck to the bladder and adhered to another area of mesentery forming a strangulating adhesive band.The mesh was partially removed.The procedure was completed and there were no patient complications.
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Search Alerts/Recalls
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