MAUDE Adverse Event Report: ACELL, INC MATRISTEM SURGICAL MATRIX MESH, SURGICAL

Model Number PSM0412

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

Patient Problem Failure to Anastomose (1028)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was conducted on discovery. At the time of this report, acell did not receive lot numbers for the devices in question. However, since it was reported that the procedures were performed in (b)(6) 2015, batch records for all possible products used by the physician in (b)(6) 2015 were reviewed. A review of the manufacturing records for these lots identified no substantial deviations and purport the products were manufactured and distributed sterile in compliance with fda, state, local, and manufacturer operating procedures. There were no reports of device failure at the time of surgery. Tests of sister grafts from the identified lots met specifications. This mdr has been filed out of an abundance of caution.

Event Description

Acell received a report of a series of anastomotic leaks in esophageal cases.

Manufacturer Narrative

This is a follow-up report for additional patient and lot number information that was received subsequent to the initial filing. A review of the manufacturing records for the lot identified no substantial deviation and demonstrated the product was manufactured and distributed in compliance with fda, state, local, and manufacturer operating procedures. Tests of a reserve sample from the same lot met specifications. This mdr has been filed out of an abundance of caution.

Event Description

Patient had an esophageal gastrectomy and experienced an anastomotic leak that required a drain to be placed in the left interior wall for drainage of fluid.

• Brand Name: MATRISTEM SURGICAL MATRIX
• Type of Device: MESH, SURGICAL
• 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 ; 8034870493
• MDR Report Key: 5464519
• MDR Text Key: 39196711
• Report Number: 3005920706-2016-00002
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141084
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2016
• Device Model Number: PSM0412
• Device Catalogue Number: PSM0412
• Device Lot Number: SM3728-35
• 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: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• 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: 02/26/2016 Patient Sequence Number: 1