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

Device Problem Insufficient Information (3190)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to the surgeon mentioning more observed strictures post study period.A review of the manufacturing records is not possible as the lot and serial number was not provided by the surgeon.We are submitting this report now, however, additional information has been requested.An update "wlll" be provided upon "reciept" of more information.

Event Description

On (b)(6) 2019 acell recieved notification from a surgeon that a current prospective study long term outcomes resulted in stricture.The study title is "esophageal reinforcement with an extracellular scaffold during total gastrectomy for gastric cancer".Surgeon mentioned more strictures observed post study period.We are submitting this report now, however, additional information has been requested.An update "wlll" be provided upon "reciept" of more information.

• 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: 9573222
• MDR Text Key: 188993338
• Report Number: 3005920706-2019-00027
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• 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): Other