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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Regurgitation (1716)

Event Date 07/21/2014

Event Type  Injury  

Manufacturer Narrative

Please note that, the other appropriate term for the device code would have been central leak.A code for the central leak is not available, for which reason code (b)(4) has been selected.A paravalvular leak was also reported, so this device code was included as well.Device location not presently known.

Event Description

On (b)(6) 2014, a (b)(6) female patient received a pvs23 to replace the native aortic valve.The procedure was performed in mini-thoracotomy and no concomitant procedures occurred.However, on (b)(6) 2014, the patient was re-operated due to device non-structural dysfunction with severe regurgitation (perivalvular leak 3+, central leak 3+).A new pvs23 was implanted in mini-sternotomy.The post-operative echo, performed on (b)(6) 2014, showed a good device functionality (9mmhg, no central/perivalvular leaks) and the patient was discharged a few days later.

Manufacturer Narrative

Based on the document review performed, no manufacturing deficiencies were identified.However, as the device was not received for analysis, no device investigation can be performed and the root cause of the reported post-operative insufficiency cannot be determined at this time.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209 s/n # (b)(4), and its stent component, were retrieved and reviewed by quality engineering at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8241298
• MDR Text Key: 132844897
• Report Number: 3005687633-2019-00101
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)161020
• 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,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2016
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 77