This mdr is being submitted due to the reported anastomotic leak after initial placement of the acell device.The acell device was not explanted.A review of the manufacturing records is not possible as the acell device, lot and serial number was not provided by the surgeon.Nevertheless, all acell devices are manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures.We are submitting this report now, however, the investigation is ongoing and more information will be provided upon completion of the investigation.
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On 7/15/2020 acell, inc.Received an adverse event report through an acell grant-sponsored study.On (b)(6) 2016 the study subject underwent an ivor-lewis esophagectomy with anastomotic reconstruction wherein the anastomosis was wrapped with an acell gentrix device.One month later, the study subject developed an anastomotic leak requiring readmission.An ir drainage followed by uneventful endoscopic stent placement was conducted and the anastomotic leak was reported as resolved on (b)(6) 2016.There are no known subsequent procedural interventions or follow-up complications.The acell device was not explanted.
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