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U.S. Department of Health and Human Services

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

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ACELL, INC MATRISTEM SURGICAL MATRIX MESH, SURGICAL Back to Search Results
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.
 
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Brand NameMATRISTEM SURGICAL MATRIX
Type of DeviceMESH, 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 Key5464519
MDR Text Key39196711
Report Number3005920706-2016-00002
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141084
Number of Events Reported1
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 Received02/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2016
Device Model NumberPSM0412
Device Catalogue NumberPSM0412
Device Lot NumberSM3728-35
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 Received03/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2014
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
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