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

Model Number PVS23

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

As per the physician medical judgment the cardiac massage performed caused the dislodgment of the perceval device.As stated in the perceval ifu precautions " patients with an implanted perceval valve may experience valve deformation when emergency cardiovascular procedures, such as cardiopulmonary resuscitation (cpr), are administered post-implant.In such cases, an echocardiographic exam post-procedure is recommended, in order to verify the preserved position and function of the valve.".

Event Description

On (b)(6) 2017 the manufacturer was notified through patient tracking of a perceval size 23 that was implanted and explanted on (b)(6) 2017.On follow up with the physician it was determined that re-operation was performed on the day of the implant ((b)(6)) due to device migration.Immediately after the implanting procedure the physician performed cardiac massage and the valve became dislodged.The patient was re-operated and the perceval valve was explanted and an edwards magna ease (unknown size) was then implanted.As per the physician medical judgment the cardiac massage performed cause the dislodgment of the perceval device.The patient outcome was good.The explanted device was discarded by the hospital.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 6997539
• MDR Text Key: 90935625
• Report Number: 3004478276-2017-00178
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)191209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/09/2019
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR