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

Model Number PSM0615

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

Patient Problem Stenosis (2263)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was conducted on discovery.A review of the manufacturing records for the lot identified no substantial deviation and purport the product was manufactured and distributed in compliance with fda, state, local, and manufacturer operating procedures.There was no report of device failure at the time of surgery.Tests of a sister graft from the same lot met specifications.This mdr has been filed out of an abundance of caution.

Event Description

Patient underwent an esophago-gastric end to end anastomosis surgery with acell device used as reinforcement.Patient subsequently developed a stricture and required balloon dilation and stent.

• Brand Name: MATRISTEM SURGICAL MATRIX PSM
• 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: 5375206
• MDR Text Key: 36206036
• Report Number: 3005920706-2016-00001
• 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: Physician
• Type of Report: Initial
• Report Date: 12/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: PSM0615
• Device Lot Number: SM4043-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2015
• Initial Date FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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