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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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MEDTRONIC HEART VALVE DIVISION OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 500
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/25/2018
Type of Reportable Event Death
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 this 29mm mitral bioprosthetic valve was implanted and explanted during the same procedure for unknown reasons.It was replaced with a 27mm mitral mechanical valve and 7 days post implant the patient passed the cause of death is unknown at this time.
 
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Brand Name
OPEN PIVOT MECHANICAL HEART VALVE
Common Device Name
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
3800 annapolis lane
minneapolis MN 55447
MDR Report Key7640978
Report Number3008592544-2018-00020
Device Sequence Number2512650
Product Code LWQ
UDI-Device Identifier00643169335059
UDI-Public00643169335059
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
P990046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/27/2018
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 Date07/15/2020
Device Model Number500
Device Catalogue Number500DM27
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2018
Initial Report FDA Received Date06/27/2018
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 Death; Required Intervention;
Patient Age56 YR
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