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

Model Number TBD

Device Problem Degraded (1153)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Death (1802); Cardiogenic Shock (2262)

Event Type  Death  

Manufacturer Narrative

The manufacturer is reporting this event in a conservative manner due to the device malfunction (structural valve deterioration) identified prior to the patient's death.However, at this time there is no further information available on the device functionality over time, treatment provided, and device relationship with the patient's death.Further investigation is ongoing and an update will be provided should further information be received.

Event Description

The manufacturer was notified on a case of early structural valve deterioration of a percival valve.As informed, a patient received the percival valve in (b)(6) 2015.Severe aortic regurgitation and moderate aortic stenosis were reported.The patient passed away in 2020 due to cardiogenic shock.No further information is presently available.

Manufacturer Narrative

Please note the correction in b4, f10.

Manufacturer Narrative

Fields updated: b4, f6, f7.The manufacturer attempted to retrieve additional information on the event, but no further information has been received to date despite the attempts.As the device was not returned for analysis and the serial number remains unknown, no further investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.Structural valve deterioration is included as a possible adverse event in the perceval ifu.Thus, the event is a known inherent risk of the device.Since no further information was provided on the event, patient's clinical history, device functionality over time, the root cause of the event and the relationship between the perceval valve with the patient's death cannot be definitively stated.Should further information be provided in the future, the manufacturer will re-assess the event and 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: 10912675
• MDR Text Key: 218484596
• Report Number: 1718850-2020-01202
• 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,Followup
• Report Date: 10/29/2020,01/14/2021

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: 12/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 10/29/2020
• Supplement Dates FDA Received: 11/26/2020; 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR