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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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MEDTRONIC HEART VALVES DIVISION HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number T510C27
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/30/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 immediately post implant of this mitral bioprosthetic valve, the valve was explanted and replaced with a valve of the same model due to user error.The physician reported there was no issue with the valve.No additional adverse patient effects were reported. .
 
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Brand Name
HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
Common Device Name
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7615681
Report Number2025587-2018-01537
Device Sequence Number19181437
Product Code LWR
UDI-Device Identifier00643169594401
UDI-Public00643169594401
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
P980043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/19/2018
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 Date08/06/2020
Device Model NumberT510C27
Device Catalogue NumberT510C27
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/01/2018
Initial Report FDA Received Date06/19/2018
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 Required Intervention;
Patient Age74 YR
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