As reported, about 4 years post-implant of the bard/davol ventralight st w/echo ps mesh, the patient was diagnosed with hernia recurrence and underwent an additional surgery for partial mesh removal and another ventralight st w/echo ps was placed.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and 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 adverse reactions section of the instructions-for-use, supplied with the device lists hernia recurrence as a possible complication.Not returned - partially explanted.
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Reported per clinical trial (b)(6): on (b)(6) 2014: subject patient underwent a robotic assisted first time recurrent midline hernia repair procedure during which a bard/davol ventralight st with echo ps was implanted using unspecified sutures.Skin closure was achieved using sutures and adhesive skin closure.The patient was discharged to home on (b)(6) 2014.On (b)(6) 2018: subject patient was presented with bulge and discomfort.On (b)(6) 2018: ct scan confirmed recurrent ventral incisional hernia.On (b)(6) 2018: subject patient underwent an reoperation for hernia recurrence and during the procedure, the mesh was partially removed (35%) and another ventralight st w/echo ps was implanted.The subject patient was discharged to home on (b)(6) 2018.Per the study clinician, the reported adverse event has been assessed as severe in severity, 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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