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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number EVOLUTPRO-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative

The device remains implanted, therefore no product analysis can be performed. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve). A conduction disturbance does not indicate a device malfunction or potential manufacturing issue. Please be informed that this information is collected via the (b)(6) registry. This prospective, multicenter registry captures implant and follow up data of patients with severe and symptomatic bicuspid aortic valve stenosis. Medtronic is not the owner of the data and does not have access to information that has not entered into the (b)(6) registry database. If additional information is received, it will be provided in a supplemental report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information from the (b)(6) registry that following the implant of this transcatheter bioprosthetic valve into a patient with a bicuspid aortic valve, an electrocardiogram (ecg) indicated an unspecified conduction disturbance. Two weeks post implant, a permanent pacemaker was placed. No additional adverse patient effects were reported. No further information was provided.

 
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Brand NameEVOLUT PRO 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 Key10216228
MDR Text Key201150559
Report Number2025587-2020-02087
Device Sequence Number1
Product Code NPT
Combination Product (Y/N)N
Reporter Country CodeDA
PMA/PMN NumberP130021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEVOLUTPRO-23
Device Catalogue NumberEVOLUTPRO-23
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 Received06/15/2020
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: 06/30/2020 Patient Sequence Number: 1
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