EVOLUT PRO TRANSCATHETER AORTIC VALVE EVOLUTPRO-26-US

MAUDE Adverse Event Report

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

Event Text Entries

[185721509] Other relevant device(s) are: product id: e vproplus-26us, serial/lot #: (b)(4), ubd: 09-jan-2022, udi#: (b)(4); product id: d-evprop2329us, serial/lot #: (b)(4), ubd: 13-jan-2021, udi#: (b)(4). Product analysis: the delivery catheter system (dcs) was discarded and the valves were not returned, therefore no product analysis can be performed. Conclusion: without the return of the product, no definitive conclusion can be made 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


[185721510] Medtronic received information that during the implant of this transcatheter bioprosthetic valve; while retrieving the delivery catheter system (dcs) from the patient, the nose cone caught on the valve and dislodge the valve. A second valve was placed and was prematurely deployed causing the patient to become decompensated. The patient was converted to surgical aortic valve repair and both transcatheter bioprosthetic valves were explanted. It was reported that the patient died during the procedure. The cause of death was not received and it is unknown if an autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-01031
MDR Report Key9903607
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-24
Date Mfgr Received2020-03-24
Device Manufacturer Date2018-06-22
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
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 PRO TRANSCATHETER AORTIC VALVE
Generic NameAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product CodeNPT
Date Received2020-03-31
Model NumberEVOLUTPRO-26-US
Catalog NumberEVOLUTPRO-26-US
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. Death 2020-03-31

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