Reported per clinical trial (b)(6): on (b)(6) 2013 - subject patient underwent primary laparoscopic midline epigastric hernia procedure and a bard/davol ventralex st mesh was fixated using mechanical sutures.Full fascial closure was achieved using mechanical sutures and full skin closure was achieved using with adhesive skin closure and sutures.The patient was discharged to home on same day.On (b)(6) 2013 - subject patient underwent physical examination and confirmed the recurrent incisional hernia with abdominal pain.On (b)(6) 2013 - subject patient underwent a laparoscopic midline epigastric recurrence hernia repair procedure using overlay technique, during which a biologic mesh was implanted.A fascial closure was obtained and full skin closure was performed.The patient was discharged to home on the same day.Per the study clinician, the reported adverse event has been assessed as severe, possibly related to the study device and to the index procedure.The outcome for this ae is reported as recovered/resolved.
|
As reported, post implant of the ventralex st mesh, the patient was diagnosed with recurrent incisional hernia and abdominal pain and underwent surgery.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and possibly related to the procedure, however, based on the information provided, no conclusions can be made.Hernia recurrence is a known inherent risk of the surgery.The adverse reactions section of the instructions-for-use supplied with the device list hernia recurrence as a possible complication.This mdr reports the ae of recurrent incisional hernia.An additional mdr was submitted to report additional ae of hematoma.Not returned - remains implanted.
|