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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Malposition of Device (2616)

Patient Problems Aortic Insufficiency (1715); Death (1802)

Event Date 04/12/2017

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2017 a small perceval valve was implanted through a right anterior thoracotomy.Upon deployment of the valve, it was noticed that the leaflets were not fully coapting.A 5 mm scope was used to determine that the valve was properly placed.The trans esophageal echo showed a large central leak, as well as a moderate pvl on the non coronary cusp.The surgeon then performed a full sternotomy to assess the valve placement.The valve was found to be seated too high on the non coronary cusp.It did appear to be properly collapsed onto the holder at the time of implantation.The valve was then removed, and annulus was resized to confirm that the proper size was implanted.The surgeon decided not to re-implant the valve lower on the non coronary side, because he felt that this would not fix the large central leak that was present.A sutured crown prt size 21 valve was then placed.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that per the patient's obituary, the patient passed away peacefully on (b)(6) 2017 following complications of surgery.

Manufacturer Narrative

The visual inspection performed on the returned prosthesis confirmed the absence of manufacturing defects.The hydrodynamic testing conducted on the returned prosthesis confirmed that the device was showing a normal leaflet kinematics with a regurgitation fraction in compliance with requirement of en iso5840:2015.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.

• 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: 6563202
• MDR Text Key: 75031049
• Report Number: 3004478276-2017-00083
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)190719
• 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
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/19/2019
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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: 78 YR