AORTIC AP 505DA22

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for AORTIC AP 505DA22 manufactured by Medtronic, Inc..

Event Text Entries

[185603372] Product analysis: no product was returned. 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


[185603376] Medtronic received information that an unknown duration post implant of this 22mm aortic mechanical valve, it was explanted and replaced with an unknown device. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008592544-2020-00025
MDR Report Key9878773
Report SourceCONSUMER
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-25
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, INC.
Manufacturer Street3800 ANNAPOLIS LANE
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAORTIC AP
Generic NameHEART-VALVE, MECHANICAL
Product CodeLWQ
Date Received2020-03-25
Model Number505DA22
Catalog Number505DA22
Device Expiration Date2014-06-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address3800 ANNAPOLIS LANE MINNEAPOLIS MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-25

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