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

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.

• Brand Name: COREVALVE TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC 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 Key: 8227700
• Report Number: 2025587-2019-00107
• Device Sequence Number: 1
• Product Code: NPT
• 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 Received: 01/08/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CRS
• Device Catalogue Number: CRS
• 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 Received: 11/05/2019
• 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