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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem Insufficiency, Valvular (1926)

Event Date 09/19/2020

Event Type  Injury  

Event Description

A perceval valve pvs23 was implanted on (b)(6) 2020 and was replaced by sapiens through valve-in-valve procedure on (b)(6) 2020 due to paravalvular leak.

Manufacturer Narrative

Since the device serial number is unknown and the device remains implanted, no further investigation is possible at this time.Based on the information available as reported for this event, the root cause of the event can be traced to a mis-sizing of the device (cause traced to the user).Should further information be made available in the future, the manufacturer will take further investigative steps as applicable and provide an update to this reporting activity.

Event Description

On 16-sep-2020 a patient received a perceval pvs23 due to aortic valve stenosis.The manufacturer was informed that the device was replaced by a corevalve through valve-in-valve procedure on (b)(6) 2020 due to paravalvular leak.The reason for the tavi implant was reportedly caused by a perceval migration in the aorta.As reported, the cause of the event (pvl and perceval migration) was identified in very large calcifications of the annulus and left ventricle.Based on the medical judgment received, it was confirmed that the perceval pvs23 was initially undersized.The manufacturer was informed that no further information will be provided.

• 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
• MDR Report Key: 10722498
• MDR Text Key: 212712158
• Report Number: 1718850-2020-01177
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/22/2020,12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention