PERCEVAL SUTURELESS AORTIC HEART VALVE PVS23 ICV1209

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 2020-03-26 for PERCEVAL SUTURELESS AORTIC HEART VALVE PVS23 ICV1209 manufactured by Livanova Canada Corp.

Event Text Entries

[185509465] On (b)(6) 2020, a perceval implant attempt occurred. The mitral annular curtain, aorta and intra-annular portion are reportedly heavily calcified. The aortic annulus was sized and a perceval medium - pvs23 was selected. The valve collapsing, implant and ballooning were performed uneventfully. Post-implant, the coaptation of leaflets was good, no pinwheeling observed. The visual inspection implied that the pvs23 was correctly deployed and juxtaposed to anatomical structures. After weaning from bypass, the echo showed moderate to high central leak. Consequently, the patient was put back on bypass and the pvs23 was explanted. A decision was made to implant a sutured valve for this patient, who ultimately received an edwards magna ease size 21. It is reported that after the perceval explant, before the sutured valve implant, there was some calcium that was previously unseen that was debrided. The patient remained stable throughout the procedure, with a good outcome after surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004478276-2020-00142
MDR Report Key9886290
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-10-04
Date Added to Maude2020-03-26
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 ContactMS FRANCESCA CROVATO
Manufacturer Street5005 NORTH FRASER WAY
Manufacturer CityBURNABY, BRITISH COLUMBIA V5J 5M1
Manufacturer CountryCA
Manufacturer PostalV5J 5M1
Manufacturer G1LIVANOVA CANADA CORP
Manufacturer Street5005 NORTH FRASER WAY
Manufacturer CityBURNABY, BRITISH COLUMBIA V5J 5M1
Manufacturer CountryCA
Manufacturer Postal CodeV5J 5M1
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 Received2020-03-26
Model NumberPVS23
Catalog NumberICV1209
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
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 2020-03-26

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