Reported per clinical trial (b)(4): (b)(6) 2016 - subject patient underwent a robotic assisted multiple recurrent midline hernia (8cm x 30cm) repair procedure during which two bard/davol ventralight st using echo ps were implanted using sutures.Full skin closure was achieved using sutures and adhesive skin closure.The patient was discharged from the hospital on(b)(6) 2017.(b)(6) 2018 - subject patient was diagnosed with recurrent ventral midline infraumbilical incisional hernia.(b)(6) 2018 - subject patient underwent surgery to repair the hernia (4.5cm x 10cm) recurrence and was implanted with bard/davol ventralight st using echo ps.The fascia was completely closed using sutures and full skin closure was achieved.The patient was discharged from the hospital on (b)(6) 2018.Per the study clinician, the reported adverse event has been assessed as severe, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.
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As reported, about two years post-implant of ventralight st using echo ps, the patient was diagnosed with a recurrent ventral incisional hernia for which the patient underwent surgical intervention.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and possibly related to the index procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The instructions-for-use (ifu) supplied with the device lists hernia recurrence as a possible complication.This mdr represents one of the ventralight st w/echo devices used during the (b)(6) 2016 surgery.An additional mdr was submitted to represent the other ventralight st w/echo used during the (b)(6) 2016 surgery.Not returned - remains implanted.
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