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

Model Number PVS23

Device Problems Material Invagination (1336); Material Too Rigid or Stiff (1544); Folded (2630)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2017

Event Type  Injury  

Event Description

It was reported that during the first attempt at implantation of a perceval valve, at the level of the annulus showed an ¿impinchment.¿ this was described as an invagination or folding in the annulus.This was not solved with the ballooning or applying warm saline.The surgeon performed a second implantation with the same perceval valve.The valve again showed the same folding but in a different location.The valve was then replaced with an intuity valve.The size of the replacement valve was not provided.

Manufacturer Narrative

The gross examination was completed and showed evident deformation at the inflow ring in correspondence to the first leaflet.Visual examination showed that the shape of the valve in the returned status, appears irregular reasonably due to the manipulation during the implant / explant steps.Moreover, it has been observed a rigidity of all the leaflets.No other deformation has been highlighted through the x-ray analysis or dimensional analysis.The analysis performed reproducing the simulated use has shown the folding of the valve only for the minimum diameter available for the implant of the specific size 23.

Manufacturer Narrative

The device history record (dhr) review was completed on 5-sep-2017.Review of the data filed in the dhr confirmed that the returned perceval aortic heart valve sn# (b)(4) satisfied all material, dimensional, and performance standards required for perceval size 23/m at the time of manufacture and release.

• 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: 6411921
• MDR Text Key: 70172314
• Report Number: 3004478276-2017-00035
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)200726
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/26/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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