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

Model Number PVS21

Device Problem Degraded (1153)

Patient Problem No Information (3190)

Event Date 09/16/2020

Event Type  Injury  

Event Description

The manufacturer was informed of an early degeneration of the perceval treated by valve in valve replacement.No further information is presently available.

Event Description

The manufacturer was informed of an early degeneration of the perceval pvs21 (size s) treated by valve in valve replacement.The patient received a valve in valve on (b)(6) 2020 with an edwards sapien 3 20 mm.No further information is presently available.

Manufacturer Narrative

Since the device was not explanted and the serial number is unknown, no device investigation is possible at this time.Based on the limited information available, it is not possible to draw a definitive conclusion on the reported event.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.The manufacturer has requested additional information on this event, but no further information has been received to date.Should additional information be provided, the manufacturer will provide an update to this reporting activity.

• 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: 10673845
• MDR Text Key: 211448256
• Report Number: 1718850-2020-01171
• 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: 09/16/2020,11/25/2020

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: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention