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

Model Number PVS25

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

Since the serial number of the involved device is unknown and given that the device was not explanted, no device investigation can be performed at this time.As such, a definitive root cause of the reported event cannot be determined at this time.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval ifu.The manufacturer has made an inquiry to retrieve the serial number of the device.If received, proper investigative actions will be taken and a follow up report will be submitted.Device not explanted.

Event Description

The manufacturer was informed on this event through the sure avr study.On (b)(6) 2019, a patient received a pvs25 in aortic position.Sizing difficulties occurred during the procedure, specified as an imperfect alignment along the non-coronary sinus.The procedure was performed in mini-thoracotomy.On (b)(6) 2019, the site reports that the patient received a permanent pacemaker due to an atrioventricular block grade iii, defined as a new conduction abnormality for this patient.Pre-operatively, the patient was in regular sinus rhythm.The patient was discharged to a rehabilitation clinic on (b)(6) 2019.

Manufacturer Narrative

The manufacturer has updated the initial reporter information with the proper contact information.The remainder of the information previously submitted remains unchanged.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9420534
• MDR Text Key: 169611501
• Report Number: 3004478276-2019-00327
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 82