PERCEVAL SUTURELESS AORTIC HEART VALVE PVS25 ICV1210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for PERCEVAL SUTURELESS AORTIC HEART VALVE PVS25 ICV1210 manufactured by Livanova Canada Corp..

MAUDE Entry Details

Report Number1718850-2019-01190
MDR Report Key9391995
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-09-06
Date Facility Aware2019-10-30
Report Date2019-10-30
Date Reported to Mfgr2019-10-30
Date Mfgr Received2019-10-30
Date Added to Maude2019-11-29
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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 CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERCEVAL SUTURELESS AORTIC HEART VALVE
Generic NameTISSUE HEART VALVE
Product CodeLWR
Date Received2019-11-29
Model NumberPVS25
Catalog NumberICV1210
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age9 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLIVANOVA CANADA CORP.
Manufacturer Address5005 NORTH FRASER WAY BURNABY, BC V5J 5M1 CA V5J 5M1


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2019-11-29

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