AORTIC VALVE GRAFT 502AG29

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 2020-03-17 for AORTIC VALVE GRAFT 502AG29 manufactured by Medtronic, Inc..

Event Text Entries

[183753607] Product analysis: the product remains implanted; therefore, 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


[183753608] Medtronic received information that during the implant of this 29mm aortic mechanical valved conduit as part of a bentall procedure, it was reported that the case was complex and took more time than usual. At the latter part of the procedure, the surgeon reported that the graft hemashield was porous and this does not occur in more straightforward cases. A reoperation was performed on the same day to perform hemostasis. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008592544-2020-00020
MDR Report Key9842993
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2019-11-18
Date Mfgr Received2020-03-03
Device Manufacturer Date2014-08-14
Date Added to Maude2020-03-17
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 VALVE GRAFT
Generic NameHEART-VALVE, MECHANICAL
Product CodeLWQ
Date Received2020-03-17
Model Number502AG29
Catalog Number502AG29
Device Expiration Date2019-08-13
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 2020-03-17

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