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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, REPLACEMENT
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MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, REPLACEMENT Back to Search Results
Model Number HC105-26
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/17/2018
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 during the implant of this bioprosthetic valved conduit, the conduit was damaged and explanted.The details regarding the damage were not reported.No additional adverse patient effects were reported.
 
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Brand Name
HANCOCK
Common Device Name
HEART-VALVE, REPLACEMENT
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7558732
Report Number2025587-2018-01349
Device Sequence Number1775347
Product Code DYE
UDI-Device Identifier00643169646544
UDI-Public00643169646544
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P870078
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) 05/31/2018
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 Date08/03/2022
Device Model NumberHC105-26
Device Catalogue NumberHC105-26
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2018
Initial Report FDA Received Date05/31/2018
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 Age60 YR
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