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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND TAVR VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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MEDTRONIC IRELAND TAVR VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number EVOLUTPRO-23-US
Device Problem Obstruction of Flow (2423)
Patient Problems Chest Pain (1776); Dyspnea (1816)
Event Date 10/04/2019
Event Type  Death  
Event Description
Tavr procedure was done on (b)(6) 2019 and medtronic evolutpro-23-us serial number (b)(4) was implanted by dr.(b)(6) at (b)(6) medical center in (b)(6).After placement our mother had chest pain and continuous shortness of breath which led to a prolonged hospitalization.Shortness of breath persisted after discharge and more recently, over past few months, complaints of chest pain with exertion.An angiogram was done by dr.(b)(6) in (b)(6) medical center, (b)(6) 2021.The doctor explained to our family that the rca was blocked by the tavr valve and by her natural leaflet and a procedure was needed to open this occlusion.She died on (b)(6) 2021 as a result of the attempted corrective procedure performed (due to this tavr complication) on (b)(6) 2021 by dr.(b)(6) at (b)(6) medical center in (b)(6).Fda safety report id# (b)(4).
 
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Brand Name
TAVR VALVE
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
MEDTRONIC IRELAND
MDR Report Key11965185
MDR Text Key255345429
Report NumberMW5101754
Device Sequence Number1
Product Code NPT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/04/2021
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? Yes
Device Operator Health Professional
Device Model NumberEVOLUTPRO-23-US
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age83 YR
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