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

Model Number PVS21

Device Problems Leak/Splash (1354); Insufficient Information (3190)

Patient Problems Aortic Insufficiency (1715); No Information (3190)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

The manufacturer was notified that on (b)(6) 2019 a patient had two percival pvs21 sutureless aortic valves ((b)(6) associated with ref# (b)(4), (b)(6) this case) explanted intra-operatively.The same day a solo smart art23smt/f15973 was implanted.No further information was received.

Manufacturer Narrative

The manufacturer received additional information on oct 14, 2019 identifying the following.A perceval valve was implanted, and when we came off pump, there was a leak.It turns out that the perceval had popped up on one side due to the anatomy of the mitral valve that had also just been replaced.He went back on pump and opened another perceval valve to try again.After ballooning the valve had popped up again in the same place.The surgeon realized that it was due to the anatomy of the patient and the way the mitral valve was pushed against the aortic valve ¿ because of this he needed a completely supra-annular valve and implanted a solo smart.There were no device issues identified.The issue was due to the patients anatomy.Patient has been checked and is doing fine.Based on this information the event was a result of patient factors and was not related to any device deficiencies.The manufacturer will not perform any further investigations and the root cause is deemed to be: cause cannot be traced to device : adverse event related to patient condition.Fields changed: b4,g4, g7, h2, h6.

Event Description

The manufacturer received additional information on oct 14, 2019 identifying the following.A perceval valve was implanted, and when we came off pump, there was a leak.It turns out that the perceval had popped up on one side due to the anatomy of the mitral valve that had also just been replaced.He went back on pump and opened another perceval valve to try again.After ballooning the valve had popped up again in the same place.The surgeon realized that it was due to the anatomy of the patient and the way the mitral valve was pushed against the aortic valve ¿ because of this he needed a completely supra-annular valve and implanted a solo smart.There were no device issues identified.The issue was due to the patients anatomy.Patient has been checked and is doing fine.

• 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: 9182786
• MDR Text Key: 173184956
• Report Number: 3004478276-2019-00279
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)220420
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR