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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, REPLACEMENT
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MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, REPLACEMENT Back to Search Results
Model Number T505C221
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/15/2018
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 approximately four years and ten months post implant of this aortic bioprosthetic valve, a transcatheter valve was implanted valve-in-valve.The reason for replacement is unknown.No additional adverse patient effects were reported.
 
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Brand Name
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
Common Device Name
HEART-VALVE, REPLACEMENT
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7567883
Report Number2025587-2018-01376
Device Sequence Number1759256
Product Code DYE
UDI-Device Identifier00643169000315
UDI-Public00643169000315
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P980043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/04/2018
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 Date05/22/2015
Device Model NumberT505C221
Device Catalogue NumberT505C221
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/15/2018
Initial Report FDA Received Date06/04/2018
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 Age75 YR
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