EVOLUT R TRANSCATHETER AORTIC VALVE EVOLUTR-26

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for EVOLUT R TRANSCATHETER AORTIC VALVE EVOLUTR-26 manufactured by Medtronic Heart Valves Division.

Event Text Entries

[185977058] Product analysis: the device remains implanted, therefore no product analysis can be performed. Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185977059] Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve dislodged after a balloon aortic valvuloplasty (bav) due to hypo-expansion of the valve. Moderate paravalvular leak (pvl) was observed. A second valve was implanted and moderate pvl was reported. No treatment was prescribed. No additional adverse patient effects were reported. Additional information was received that the first valve dislodged after a balloon aortic valvuloplasty (bav) due to hypo-expansion. No additional adverse patient effects were reported.?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-01040
MDR Report Key9908967
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2018-11-27
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC HEART VALVES DIVISION
Manufacturer Street1851 E DEERE AVE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal Code92705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVOLUT R TRANSCATHETER AORTIC VALVE
Generic NameAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product CodeNPT
Date Received2020-03-31
Model NumberEVOLUTR-26
Catalog NumberEVOLUTR-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC HEART VALVES DIVISION
Manufacturer Address1851 E DEERE AVE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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