As reported, post implant of the xenmatrix, the patient was diagnosed with recurrent ventral hernia and underwent reoperation to repair recurrent ventral hernia.The clinician has assessed the patient¿s postoperative course as possibly related related to the study device and definitely related to the index procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 21 units released for distribution in november,2013.Not returned - remains implanted.
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Per clinical trial (b)(4): on (b)(6) 2013 the subject patient underwent a primary open ventral midline hernia repair, during which a xenmatrix surgical graft was placed in underlay fashion on the intra-peritoneal region and was fixated using sutures.Full skin closure was achieved with sutures.The patient was discharged to home on(b)(6) 2014.On (b)(6) 2014, the patient was diagnosed with recurrent ventral hernia.On (b)(6) 2015, the patient underwent reoperation to repair recurrent ventral hernia.The patient was discharged to home on (b)(6) 2015.This ae is clinically assessed to be possibly related to the study device and definitely related to the procedure.This has been assessed as of moderate severity and has resolved.The reported adverse event does not meet the definition of an sae (serious adverse event).
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