It was reported that the suture "made the hole to the stomach larger" and "air have leaked to the peritoneum." the patient, a child, required surgery.Additional details: the procedure was performed on ((b)(6) 2020 and the placement "looked good." the patient started having stomach aches, and a new x ray was performed on (b)(6) 2020, which showed free gas in the abdomen, requiring surgery.The air leak had occurred along one anchor suture, and the suture was "chafing bigger holes in the stomach than it should." per the reporter, "we have not fully understood the patient's underlying diseases, which is why this happened to everything else." per additional information received 08 apr 2020, the patient has an underlying and unusual tissue problem/disease, and the healthcare provided does not believe the device failed.
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