An investigation update is provided below: upon review of medical records provided by the patient, it is unlikely that the ovitex device caused or contributed to the issues noted in the original report.The patient reported a complex medical history prior to hernia repair with ovitex.The initial procedure was also conducted together with a tif procedure that implanted multiple permanent fasteners.Multiple endoscopies showed no injuries to the esophagus and that the tif valve was intact (4 and 6 months after initial surgery, respectively).During a (b)(6) 2020 (10 months post-op) endoscopy, an extruded suture was removed but no extruded mesh was noted.In (b)(6) 2021, (17 months after initial surgery) the tif was attempted to be reversed.No records are available after this time.A batch record review of the lot utilized in the original procedure showed no non-conformances or anomalies that may have caused or contributed to the issue noted.
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