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

Model Number PVS23

Device Problems Bent (1059); Difficult to Open or Close (2921)

Patient Problem High Pulmonary Arterial Wedge Pressure (2480)

Event Date 04/13/2017

Event Type  Injury  

Event Description

It was reported that this perceval valve was implanted and explanted on (b)(6) 2017.It was stated that after implantation, the surgeon noticed a small bend at the non-coronary leaflet position.They used a balloon and everything looked fine and they closed the aorta.The patient could not be weaned from bypass and had high pulmonary pressure.In attempting to wean the patient off bypass, the high pulmonary pressure was observed.It was suspected, and later confirmed through tee, that the valve was not opening effectively to allow proper flow, causing the pressure increase in the pulmonary system.Due to the high pulmonary pressures seemingly caused by the valve not opening properly, it was suspected that this was due to the flexible nature of the stent being affected by the ¿fatty tissues at the atrium level.¿ it was determined by the surgeon that a more rigid-stented valve would allow better flow.Therefore, they re-opened the aorta and decided to explant the perceval and implant magna size 21.There was a delay in the surgery of about 30 or 45 minutes.

Manufacturer Narrative

The device was received for analysis on june 01, 2017.Gross examination was completed.

Manufacturer Narrative

The returned device was evaluated on (b)(6) 2017.A visual inspection was performed on the returned prosthesis, and confirmed the absence of manufacturing defects.A p-pn gauge test confirmed the absence of dimensional irregularities.A simulation of the valve deployment, performed with the returned device, was not able to produce abnormal leaflet mobility, even with conservative configuration.A partial manufacturing and material records review for the valve, and complete review for the stent component, was completed on 27-sep-2017.The results confirmed that the components satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the analyses performed, the reported event cannot be explained by any factor intrinsic to the involved device.According to the physician's narrative, it is likely that "fatty tissues at the atrium level" contributed to the event.As such, the event can reasonably be attributed to the patient anatomy, and is considered to be not-device-related.

• 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
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 fraser north way; burnaby
• Manufacturer Contact: francesca crovato ; 5005 fraser north way; burnaby, bc
• MDR Report Key: 6560583
• MDR Text Key: 74989763
• Report Number: 3004478276-2017-00081
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)181218
• 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,Followup,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/18/2018
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• 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: 85 YR