MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS23

Device Problems Perivalvular Leak (1457); Folded (2630)

Patient Problems Calcium Deposits/Calcification (1758); Cardiac Arrest (1762)

Event Date 03/15/2017

Event Type  Injury  

Event Description

The manufacturer was notified on mar 15, 2017 that a female patient underwent a perceval implant for an isolated avr.Anatomical considerations were identified prior to the implant.The annulus and stj measured 21 and 25 respectively prior to decalcification.The anesthetist commented that the calcification of the valve did cause a slight elliptical shape which was decalcified to a circular annulus.Calcified leaflets came away easily and surgeon was satisfied with the decalcification and compliance of the annulus before implanting.The mitral valve was heavily calcified, however the surgeon felt this had no consequence to the pressures on the aortic valve.During implantation, the sizing went to plan and the surgeon felt this was a straight forward measurement.The translucent end of the m sizer slipped through the annulus easily, and the opaque end was held up and could not be passed through the annulus.There was no concern or questioning between sizers at the time.A medium perceval was selected with confidence.Upon deployment there were no displays of irregular implantation.Leaflets coapted nicely, no visible annulus, and no crimping or buckling of the inflow ring or leaflets was seen.The surgeon was happy with his assessment and closed the aortotomy to come off bypass.During testing of the valve, per the instructions for use, the patient went into ventricular fibrillation and they defibrillated multiple times.No elevation of pulmonary pressures.The toe presented a trivial pvl at the ncc, which progressively worsened to include cvl.They re-opened and explanted the valve to reveal a buckling of the inflow ring at the ncc causing the pvl and cvl.They proceeded to use a traditional sutured valve.

Manufacturer Narrative

The valve was received for analysis on may 05, 2017.Gross examination was completed and additional analysis is underway.

Event Description

The replacement valve used was a trifecta size 21.

Manufacturer Narrative

On receipt of the device gross examination was performed.After decontamination, the valve was visually inspected without highlight to any particular elements of non conformity according to the specifications.The shape of the valve was irregular probably due to the manipulation during the implant/explant steps.Traces of blood were observed both on the inflow and outflow side.The visual inspection performed on the returned prosthesis confirmed the absence of manufacturing defects.No irregularity was identified with the p-np gauge test.The go-no go test confirmed the absence of dimensional irregularity.During the simulation, the valve was implanted in the silicon aortic root, miming the real and conservative (d-shape) conditions, and the simulation of the ballooning phase.In particular, the anomalous behavior (i.E.Tendence of kinking) was not replicated during the test.This evidence applies for the returned valve as shown in the final result after the ballooning phase including also the worst dimensional case.The valve remained fixed within the annulus and did not shown irregularities during the simulation.The simulation of the valve deployment, performed with the returned device in conservative setup, was not able to replicate the anomalous behaviour of tendence of valve kinking.The results of the document review for the perceval ¿ pvs 23 / m ¿ sn (b)(4) confirmed that the device satisfied all material, dimensional and performance standards required for a perceval valve size 23 / m at the time of manufacture and release.Based on the performed analyses the reported event cannot be explained by any factor intrinsic in the involved device.Based on the action taken of the perceval valve size 23 mm explanted and a trifecta size 19 implanted it is possible that there was a mis-match in sizing which would attribute to this event.

Manufacturer Narrative

Corrected information: the replacement device information was corrected.A magna ease valve, rather than a trifecta, was implanted.This information does not change our investigations or conclusions.

Event Description

The replacement valve used was a 19 mm carpentier edwards magna ease valve.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 fraser north way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 fraser north way; burnaby, bc
• MDR Report Key: 6492362
• MDR Text Key: 72780504
• Report Number: 3004478276-2017-00061
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)181015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/15/2018
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention