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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC FREESTYLE PORCINE AORTIC BIOROOT, MODEL 995
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MEDTRONIC FREESTYLE PORCINE AORTIC BIOROOT, MODEL 995 Back to Search Results
Model Number 995
Device Problems Contamination (1120); Microbial Contamination of Device (2303)
Patient Problems Abscess (1690); Endocarditis (1834); Heart Failure (2206); Fungal Infection (2419)
Event Date 06/01/2015
Event Type  No Answer Provided  
Event Description
The medtronic freestyle aortic root bioprosthesis was implanted on (b)(6) 2015.Within three months, the pt had severe heart failure from aortic valve endocarditis and aortic root abscess.The valve and root have now been explanted and are growing a black mold (working on id still).It would seem that this valve was either contaminated during manufacture or at the time of the implantation, as this immunocompetent pt should not otherwise have a severe black mold infection at that side.At the time of the operation, an unusually large amount of "bioglue" (manufactured by cryolife) was also used.Reason for use: replacement of an aortic aneurysm.
 
Event Description
Add'l info received from reporter on 07/10/2015: dr.(b)(6) states the date of the operation was (b)(6) 2015.Also last night pt took a turn for the worse.Her brain herniated and pt is not expected to survive.
 
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Brand Name
FREESTYLE PORCINE AORTIC BIOROOT, MODEL 995
Type of Device
FREESTYLE PORCINE AORTIC BIOROOT, MODEL 995
Manufacturer (Section D)
MEDTRONIC
MDR Report Key4888367
MDR Text Key6016624
Report NumberMW5043476
Device Sequence Number1
Product Code LWR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/26/2015
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received06/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number995
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
"BIOGLUE" (MANUFACTURED BY CRYOLIFE)
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age46 YR
Patient Weight130
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