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

Model Number TBD

Device Problem Degraded (1153)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The manufacturer was informed that a patient who received a perceval valve in 2016, will receive a transcatheter aortic valve implantation (tavi) due to valve degeneration.No further information is presently available.

Manufacturer Narrative

Since the device was not explanted and no further information has been received to date, no further investigation is possible at this time.Thus, the root cause cannot be established at this time.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 will revisit the investigation should further information be provided.

Event Description

The manufacturer was informed that a patient who received a perceval valve in 2016, will receive a transcatheter aortic valve implantation (tavi) due to valve degeneration.No further information is presently available.The manufacturer received additional information confirming that the tavi has been done although the exact date was not informed.No complications or patient adverse impact occurred.

• 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: 10723231
• MDR Text Key: 212703773
• Report Number: 1718850-2020-01178
• 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: 09/24/2020,12/02/2020

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: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other