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

Model Number PVS27

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/26/2020

Event Type  Injury  

Event Description

The manufacturer was notified that on (b)(6) 2020, a perceval valve pvs27 was implanted and explanted on the same day.A carbomedics top hat aortic valve s5-025 was finally implanted.No further information was received.

Event Description

The manufacturer received additional information identifying that the perceval did not fit right due to anatomical anomalies and the site decided to implant the top hat instead due to the young age of the patient.30 minutes of additional x-clamp time was added to the procedure.The patient had an uneventful recovery and remains well.

Manufacturer Narrative

The manufacturer received additional information identifying that the perceval did not fit right due to anatomical anomalies and the site decided to implant the top hat instead due to the young age of the patient.30 minutes of additional x-clamp time was added to the procedure.The patient had an uneventful recovery and remains well.The manufacturing and material records for the perceval heart valve, model #icv1211 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1211) perceval heart valve at the time of manufacture and release.Given the additional information the manufacturer will not perform any further investigations and will proceed with the conclusion of the event analysis.The event is attributable to the patients anatomical anomalies and thus the root cause is deemed to be cause traced to patient geometry, event not related to the device.

• 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: 10440298
• MDR Text Key: 211451816
• Report Number: 3004478276-2020-00177
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)210912
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention