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 2020-03-20 for PERCEVAL SUTURELESS AORTIC HEART VALVE PVS25 ICV1210 manufactured by Livanova Canada Corp..

Event Text Entries

[188982865] The manufacturer was notified of a serious adverse event involving a patient with a perceval pvs25 sutureless aortic heart valve. The information was as follows. On (b)(6) 2019 the patient passed away as a result of mesenteric ischemia, secondary to failed perceval bioprosthesis and iatrogenic root rupture. No further information was received including the date of implant.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1718850-2020-01047
MDR Report Key9862986
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2019-11-11
Date Facility Aware2020-03-11
Report Date2020-03-11
Date Reported to Mfgr2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-20
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 Received2020-03-20
Model NumberPVS25
Catalog NumberICV1210
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age19 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLIVANOVA CANADA CORP.
Manufacturer Address5005 NORTH FRASER WAY BURNABY, BRITISH COLUMBIA V5J 5M1 CA V5J 5M1

Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-20
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