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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC VALVE GRAFT; HEART-VALVE, MECHANICAL
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MEDTRONIC, INC. AORTIC VALVE GRAFT; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 502AG
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/14/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 1 year 6 months post implant of this aortic mechanical valve it was explanted and replaced with the same size and model valve for unknown reasons.No additional adverse patient effects were reported.
 
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Brand Name
AORTIC VALVE GRAFT
Common Device Name
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
MDR Report Key7130076
Report Number3008592544-2017-00069
Device Sequence Number1690737
Product Code LWQ
UDI-Device Identifier00643169333680
UDI-Public00643169333680
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P990046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/19/2017
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 Date12/02/2018
Device Model Number502AG
Device Catalogue Number502AG25
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/27/2017
Initial Report FDA Received Date12/19/2017
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 Age49 YR
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