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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Folded (2630)

Patient Problem Death (1802)

Event Date 11/26/2016

Event Type  Death  

Manufacturer Narrative

The valve was returned for analysis on mar 20, 2017.The gross examination has been completed on mar 21, 2017.

Event Description

The perceval s valve was implanted on (b)(6) 2016.A few hours after successful implantation, the valve developed a severe paravalvular leak because of folding/ lateral collapse of its ring.The valve was explanted and a new aortic valve was implanted.However, because of hemodynamic instability, the patient died in the operation room.

Event Description

Additional information was received on apr 6, 2017.: the patient had emergency replacement to replace the valve with a carpentier-edwards perimount magna ease bio-prosthesis carried 19 mm.It was stated it was also necessary to extend the small annulus.In the patient, apart from a calcified ascending aorta, there were no other known secondary diseases.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and nitinol stent component, model #icv1208 , s/n # (b)(4) were pulled and reviewed by quality control at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Visual inspection and p-np gauge dimensional analysis further confirmed that the valve was in line with the release specifications.X-ray analysis confirmed the absence of structural fracture in the valve stent.Simulation of the valve collapsing, deployment and ballooning in a silicon aortic root according with the indication included in the ifu (perceval s ¿ sutureless aortic heart valve ¿ instructions for use ¿ic0215001345 rev.H) revealed that it was not possible to replicate the reported folding event.Based on the performed analyses, it was concluded that the reported event cannot be explained by any factor intrinsic to the involved device.The physician report indicated that an aortic root enlargement was necessary to implant a 19 mm carpentier-edwards perimount magna ease bio-prosthesis following the perceval explant.This indicates that the vessel was smaller than 19 mm, which is the minimum allowable annulus size for a pvs size 21 (21 mm) perceval, and suggests that the valve was oversized.Over-sizing is warned against in the perceval ifu due to the possibility of stent folding resulting in regurgitation.Given this information, and our inability to replicate the reported folding event in a simulation, it was concluded that this event likely occurred due to mis-sizing, and was not valve related.(b)(4).

• 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: 6430328
• MDR Text Key: 70734841
• Report Number: 3004478276-2017-00038
• Device Sequence Number: 1
• Product Code: LWR
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/08/2017
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2013
• 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): Death
• Patient Age: 81 YR
• Patient Weight: 60