MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX THIN

Model Number PSM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

On 7/15/2020 acell, inc.Received an adverse event report through an acell grant-sponsored study.On (b)(6) 2018 the study subject underwent a total gastrectomy with abdominal regional lymphadenectomy and roux-en-y reconstruction wherein the anastomosis was wrapped with an acell gentrix device.On (b)(6) 2018 the study subject developed an anastomotic leak.An ir drainage followed by uneventful endoscopic stent placement was conducted and the anastomotic leak was reported as resolved on (b)(6) 2018.There are no known subsequent procedural interventions or follow-up complications.The acell device was not explanted.

• Brand Name: GENTRIX SURGICAL MATRIX THIN
• Type of Device: GENTRIX SURGICAL MATRIX THIN
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney drive; columbia, md
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia, md
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, md ; 9538558
• MDR Report Key: 10388609
• MDR Text Key: 202510526
• Report Number: 3005920706-2020-00007
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PSM
• Device Catalogue Number: PSM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention