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

Model Number PVS27

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Activation Failure (3270)

Patient Problem Aortic Insufficiency (1715)

Event Date 07/25/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a pvs27 was implanted in the aortic position.It is reported that the sizing was performed correctly, using the perceval set of sizers.Initially, the valve showed an excellent hemodynamic, with no leaks.However, the post-operative echo control performed on (b)(6) 2019 showed 2 perivalvular leaks, one mild in the non-coronary sinus and one moderate-severe in the right coronary sinus.No stent folding was detected.Consequently, on (b)(6) 2019, a re-operation was performed to explant the pvs27 and replace it with a magna ease 25mm.The re-do surgery was performed uneventfully and the patient is doing well.It is reported that the patient's native valve was not bicuspid and was heavily calcified.However, no issues occurred intraoperatively with the implant, all the calcification was removed with preservation of the annulus.It is reported that, postoperatively, the valve did not appear as fully expanded.

Event Description

On (b)(6) 2019, a pvs27 was implanted in the aortic position.It is reported that the sizing was performed correctly, using the perceval set of sizers.Initially, the valve showed an excellent hemodynamic, with no leaks.However, the post-operative echo control performed on (b)(6) 2019 showed 2 perivalvular leaks, one mild in the non-coronary sinus and one moderate-severe in the right coronary sinus.No stent folding was detected.Consequently, on (b)(6) 2019, a re-operation was performed to explant the pvs27 and replace it with a magna ease 25mm.The re-do surgery was performed uneventfully and the patient is doing well.It is reported that the patient's native valve was not bicuspid and that it was heavily calcified.However, no issues occurred intraoperatively with the implant, all the calcification was removed with preservation of the annulus.Based on the surgeon's assessment, the valve did not appear as fully expanded, thus it got tilted.Pre-operatively, the aortic annulus measured 23mm.

Manufacturer Narrative

As the serial number is unknown and the explanted prosthesis is not available for return, no device investigation can be performed at this time.Based on the available information on the pre-operative dimension of the annulus (23mm) and the device ultimately implanted in the patient (magna ease 25), it is possible that the perceval pvs27 was initially oversized, thus contributing to the not full expansion of the stent and subsequent perivalvular leak.

• 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: 9195063
• MDR Text Key: 163055749
• Report Number: 1718850-2019-01111
• Device Sequence Number: 1
• Product Code: LWR
• 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: 09/20/2019,11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 83