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

Model Number PVS27

Device Problem Positioning Problem (3009)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

The patient required aortic valve replacement due to severe calcification of his native valve.The valve was sized for a extra large perceval which was brought to the field.Three guiding sutures were placed at the commissure nadirs and the valve delivered.Positioning appeared excellent with no significant evidence for under oversizing.Per the ifu, balloon dilation of the valve was performed.The aorta was then closed in a double layer fashion.However during the de-airing process, it was noted the valve positioning was extremely altered and was now noted in the left ventricular cavity.It required the patient to be placed on cardio-pulmonary bypass again.The perceval valve was retrieved and replaced by another manufacturer's valve.No further events occurred from this situation and the patient recovered.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 12007801
• MDR Text Key: 256454933
• Report Number: 12007801
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PVS27
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 106