BOSTON SCIENTIFIC CORPORATION PFR KIT PINNACLE LITE POSTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); No Code Available (3191)
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Event Date 11/26/2013 |
Event Type
Injury
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Manufacturer Narrative
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This event was reported by the patient's legal representation.The implant surgeon is: (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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Note: this manufacturer report pertains to the second of two devices implanted in the same patient.The first device was an uphold vaginal support system implanted (b)(6) 2013.It was reported to boston scientific corporation that a pelvic floor repair (pfr) kit pinnacle lite posterior was implanted during a revision surgery, anterior vaginal wall mesh repair and insertion of pinnacle posterior procedure performed on (b)(6) 2013 to treat prolapse.As reported by the patient's attorney, during the procedure, the patient had a revision surgery for erosion and removal of left arm of the anterior vaginal wall mesh of the previously-implanted uphold as well as insertion of the pinnacle posterior.Furthermore, on (b)(6) 2017, the patient underwent an anterior-posterior vaginal repair, revision of vaginal sling and laparotomy/ suprapubic suspension.After the procedure, it was observed that a large piece of mesh was removed from the nuclear and lateral parts, and floseal was used to repair the double layer skin.
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Search Alerts/Recalls
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