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U.S. Department of Health and Human Services

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

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ACELL, INC. GENTRIX SURGICAL MATRIX THIN Back to Search Results
Model Number PSM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure to Anastomose (1028)
Event Date 04/13/2016
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 not explanted. 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 7/15/2020 acell, inc. Received an adverse event report through an acell grant-sponsored study. On (b)(6) 2016 the study subject underwent an ivor-lewis esophagectomy with anastomotic reconstruction wherein the anastomosis was wrapped with an acell gentrix device. One month later, the study subject developed an anastomotic leak requiring readmission. An ir drainage followed by uneventful endoscopic stent placement was conducted and the anastomotic leak was reported as resolved on (b)(6) 2016. There are no known subsequent procedural interventions or follow-up complications. The acell device was not explanted.
 
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Brand NameGENTRIX SURGICAL MATRIX THIN
Type of DeviceGENTRIX SURGICAL MATRIX THIN
Manufacturer (Section D)
ACELL, INC.
6640 eli whitney drive
columbia, md
Manufacturer (Section G)
ACELL, INC.
6640 eli whitney dr.
columbia, md
Manufacturer Contact
barry brainard
6640 eli whitney dr.
columbia, md 
9538558
MDR Report Key10388530
MDR Text Key202510442
Report Number3005920706-2020-00010
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182259
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPSM
Device Catalogue NumberPSM
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 Received07/15/2020
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 Treatment Data
Date Received: 08/10/2020 Patient Sequence Number: 1
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