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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC; HEART-VALVE, REPLACEMENT
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MEDTRONIC HEART VALVES DIVISION MOSAIC; HEART-VALVE, REPLACEMENT Back to Search Results
Model Number 305C25
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)
Date of Event 05/22/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that 11 years and 1 month post implant of this bioprosthetic aortic valve, a transcatheter valve was implanted valve-in-valve due to severe stenosis and severe insufficiency.No additional adverse patient effects were reported. .
 
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Brand Name
MOSAIC
Common Device Name
HEART-VALVE, REPLACEMENT
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key8650095
Report Number2025587-2019-01719
Device Sequence Number2340383
Product Code DYE
UDI-Device Identifier00885074133133
UDI-Public00885074133133
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P990064
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/29/2019
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
Operator of Device Health Professional
Device Expiration Date11/16/2010
Device Model Number305C25
Device Catalogue Number305C25
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/22/2019
Initial Report FDA Received Date05/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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