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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS LIFE TECHNOLOGIES, INC SUPPLE PERI-GUARD MESH, SURGICAL

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SYNOVIS LIFE TECHNOLOGIES, INC SUPPLE PERI-GUARD MESH, SURGICAL Back to Search Results
Catalog Number PC-0814SN
Device Problems Break (1069); Clumping in Device or Device Ingredient (1095); Microbial Contamination of Device (2303)
Patient Problem Abscess (1690)
Event Date 10/25/2017
Event Type  malfunction  
Event Description
Four months after elective aortic valve replacement/root enlargement was performed on a young adult, the patient required repeat surgery for a pseudoaneurysm of the ascending aorta and a small perivalvular abscess. Vegetation was noted to be attached to the previously implanted bovine pericardium which had broken down and shriveled into a clump of tissue in the mid anterior wall of the aorta. This bovine graft material was removed, cultured, and grew aspergillus. The source of the aspergillus is suspected to have been introduced from the air during implantation. However, out of an abundance of caution, this report is being submitted.
 
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Brand NameSUPPLE PERI-GUARD
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SYNOVIS LIFE TECHNOLOGIES, INC
2575 university ave w
saint paul MN 55114
MDR Report Key7112278
MDR Text Key94693943
Report Number7112278
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPC-0814SN
Device Lot NumberSP17E02-1229030
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/04/2017
Event Location Hospital
Date Report to Manufacturer12/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1
Treatment
IN ADDITION TO THE BOVINE GRAFT TO THE AORTA, PATI
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