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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

Given that the valve was ultimately implanted successfully following additional proctoring regarding the appropriate tension on the guiding sutures, the event can reasonably be attributed to the inexperience and training of the surgeon.Based on the successful implant of the device, there is no information to suggest device deficiency.The trace paravalvular leak identified after re-implantation was attributed to slight malpositioning of the valve, which can similarly be related to the surgeon's experience.As such, no further investigation is warranted.This mdr has already been submitted july 10, 2018 and resubmitted due to missing 3rd acknowledgment.Device still implanted.

Event Description

Summary: a perceval pvs23 was implanted via full sternotomy.The valve was reportedly sized appropriately in the presence of a proctor.The valve was collapsed and deployed; however, echocardiography revealed central and paravalvular leak after coming off bypass.The valve appeared to be tilted in the annulus.Cardiopulmonary bypass was re-established and cross clamp was applied.Visual inspection confirmed that the valve was tilted.The valve was removed using the z-maneuver, then re-collapsed and re-implanted off label.The valve was re-implanted with additional coaching from the proctor on the tension of the guiding sutures.The valve was re-collapsed, re-deployed, and the aortotomy was closed.The second cross-clamp time was 24 minutes.Echocardiography revealed trace pvl, and it was suggested that this may be due to the valve being slightly tilted in the annulus.It was decided that the valve would be left in place.The mean gradient was 13 mmhg.It was reported that the patient was not affected, and was successfully weaned from bypass and transferred to icu.

• 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 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: 7693123
• MDR Text Key: 114140497
• Report Number: 3004478276-2018-00237
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)201117
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• 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: 65 YR