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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problems Aortic Insufficiency (1715); Complete Heart Block (2627)

Event Type  Injury  

Event Description

The manufacturer was notified on oct 28, 2016 of the following from a scientific paper: during the postoperative course, he patient experienced total av block, requiring pacemaker implantation.At discharge, tte showed a trace of pvl.The patient missed their follow-up appointment and was readmitted 15 months later with congestive heart failure.The tte showed severe pvl caused by distorted and displaced valve.Reoperation was performed via median sternotomy and the valve was explanted with no signs of infection or deterioration.After complete calcium debridement, the appropriate perceval sizing was one size larger than at first operation.A trifecta 23 mm was then implanted and the postoperative course was uneventful.

Manufacturer Narrative

Additional information was requested to the hospital.However, no further information including the device serial number was able to be obtained.Therefore, based on the limited information provided no conclusion can be drawn for this event.

Event Description

This is a case report where the authors speculate that an initial undersize was the cause for a late migration (even though they replaced the perceval m with a trifecta 23!), thus they warn the reader of the importance of a careful sizing after calcium debridement.The stent of the valve appears quite deformed, thus i am wondering if the migration was due to a patient anatomic feature (eg.Hypertrophic septum causing instability and later dislodgment?).Authors: gilles amr, md, msc1; aly ghoneim, md1; geneviève giraldeau, md2; philippe demers, md, msc, frcsc1.- from the department of cardiac surgery, montreal heart institute, montréal, québec, canada; and the department of cardiology, montreal heart institute, montréal, québec, canada.Central message: we report the first case of a delayed proximal migration of a perceval bioprosthesis 15 months after implantation.Postoperative course - total av block, requiring pacemaker implantation.At discharge, tte showed a trace of pvl.The patient missed follow-up appointment and was readmitted 15 months later with congestive heart failure.The tte showed severe pvl caused by distorted and displaced valve.Reoperation via median sternotomy.Valve was explanted with no signs of infection or deterioration.After complete calcium debridement, the appropriate perceval sizing was one size larger than at first operation.A trifecta 23 mm was then used.The postoperative course was uneventful.Update 21st jun: r.Gordan -no more info received after several attempts at follow up.

• 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 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 6127477
• MDR Text Key: 60875748
• Report Number: 3004478276-2016-00156
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 80 YR