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

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

Patient Problem Failure to Anastomose (1028)

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 explanted; however it is not available for evaluation. 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 (b)(6) 2019, acell, inc. Was notified by a physician that their patient developed an anastomotic leak and became septic, four (4) days after performing an anastamosis repair wrapped with an acell gentrix device. The surgeon was unable to provide the date of the surgery and the acell device used. We are submitting this report now, however, the investigation is ongoing and more information will be provided upon completion of the investigation.

• Brand Name: GENTRIX SURGICAL MATRIX THIN
• Type of Device: GENTRIX SURGICAL MATRIX THIN
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 4109538558
• MDR Report Key: 8745294
• MDR Text Key: 149546176
• Report Number: 3005920706-2019-00013
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/28/2019 Patient Sequence Number: 1