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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

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MEDTRONIC HEART VALVES DIVISION COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number CRS
Device Problem Insufficient Information
Event Date 11/05/2018
Event Type  Death  
Manufacturer Narrative

Tvt registry exemption number: e2014038. Quarterly reporting period: q4 2018 total number of events being summarized: 472 under the terms and conditions of the registry, anonymized patient demographics details and limited details were provided regarding the adverse events and outcomes. The reported event information did not include any device-specific identifying information, location where the events occurred or the specific dates of the events. Without such information, it cannot be determined if any of these events were previously reported to medtronic or the fda maude database, or if any devices were explanted and returned to medtronic for analysis. The listed date of death and event date is the date the information was received by medtronic. The date of death was noted as the date of awareness due to the de-identified nature of the data. If information is provided in the future, a supplemental report will be issued.

 
Event Description

This report summarizes 472 death events. Medtronic received information regarding patient/device events via a third-party post-implant device registry (the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry). The information in this report was provided to medtronic in a de-identified format, and has been organized into summaries of observations related to patient deaths and serious injuries.

 
Manufacturer Narrative

Exemption number: e2014038. Quarterly reporting period: q4 2018. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameCOREVALVE TRANSCATHETER AORTIC VALVE
Type of DeviceAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view , MN 55112
7635055378
MDR Report Key8227700
Report Number2025587-2019-00107
Device Sequence Number1
Product CodeNPT
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCRS
Device Catalogue NumberCRS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2019 Patient Sequence Number: 1
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