MAUDE Adverse Event Report: LIVANOVA CANADA CORP PERCEVAL SUTURLESS AORTIC HEART VALVE; TISSUE HEART VALVES

Model Number PVS23

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

Patient Problem No Information (3190)

Event Date 06/25/2017

Event Type  Injury  

Manufacturer Narrative

The physician has indicated as per medical judgment that a possible over-sizing of the perceval valve may have contributed to this event.Device not explanted.

Event Description

On july 4th 2017 the manufacturer was notified of the following event: on (b)(6) 2017 a perceval size 23 was implanted.Two (2) days from the implant on (b)(6) a leak was observed and the inflow stent appeared to be folded by echo.The physician performed a dilation with a balloon in the cath lab.This procedure gave a positive outcome.Ten (10) days post implant a valve in valve procedure was then performed, a sapien size 23 was implanted.The patient is doing well.

Manufacturer Narrative

The complete manufacturing and material records for the perceval heart valve and nitinol stent component, model #icv1209 , s/n # (b)(4) were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) percevalheart valve at the time of manufacture and release.As the device was not explanted no further investigation is possible at this time.The physician has indicated as per medical judgment that a possible over-sizing of the perceval valve may have contributed to this event.

• Brand Name: PERCEVAL SUTURLESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6760887
• MDR Text Key: 81627283
• Report Number: 3004478276-2017-00140
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)200727
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/27/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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): Hospitalization; Required Intervention