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

Model Number PVS23

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Date 08/13/2020

Event Type  Injury  

Event Description

The manufacturer received the following information through the sure avr registry: on (b)(6) 2020, a perceval valve pvs23 was implanted in aortic position via median sternotomy.A concomitant cabg procedure was performed.The site reported a post-operative complete heart block / a new conduction abnormality that occurred on (b)(6) 2020, and required a permanent pacemaker to be implanted on (b)(6) 2020.The patient was discharged from hospital on (b)(6) 2020.The echo performed before the discharge ((b)(6) 2020) showed the absence of device malfunctions.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(6) and the nitinol stent as they pertain to the reported event, were retrieved and reviewed by the manufacturer.The results confirmed that this valve and component satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Since the device remains implanted, no further device 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.However, per the document review performed, no manufacturing deficiencies were identified.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.

• 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: 10988553
• MDR Text Key: 220912054
• Report Number: 1718850-2020-01215
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230131
• 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: 11/12/2020,02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2021
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 88