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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION THV 1000-23 3F AORTIC BIO 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE
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MEDTRONIC HEART VALVES DIVISION THV 1000-23 3F AORTIC BIO 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number 1000-23
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Stenosis (2263)
Date of Event 07/20/2017
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.
 
Event or Problem Description
Medtronic received information that four years and eight months years post implant of this bioprosthetic valve, a transcatheter valve was implanted valve-in-valve due to stenosis of the bioprosthetic valve.No other adverse patient effects were reported.
 
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Brand Name
THV 1000-23 3F AORTIC BIO 23MM
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 Key6814864
Report Number2025587-2017-01462
Device Sequence Number137033
Product Code LWR
UDI-Device Identifier00613994961617
UDI-Public00613994961617
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P060025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/01/2017
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 Date11/01/2016
Device Model Number1000-23
Device Catalogue Number1000-23
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/01/2017
Initial Report FDA Received Date08/23/2017
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 Age59 YR
Patient Weight96
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