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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE
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MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number HC15025
Medical Device Problem Code Gradient Increase (1270)
Health Effect - Clinical Code Pulmonary Valve Stenosis (2024)
Date of Event 06/15/2018
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 9 years and 11 months post implant of this pulmonary valved conduit, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve due to stenosis and elevated gradients.No additional adverse patient effects were reported. .
 
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Brand Name
HANCOCK
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 Key7648691
Report Number2025587-2018-01638
Device Sequence Number275121
Product Code LWR
UDI-Device Identifier00681490908832
UDI-Public00681490908832
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P790007
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/28/2018
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 Date11/05/2012
Device Model NumberHC15025
Device Catalogue NumberHC15025
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/15/2018
Initial Report FDA Received Date06/28/2018
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 Age25 YR
Patient Weight82
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