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

Model Number PVS23

Device Problem Activation Failure (3270)

Patient Problem No Information (3190)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

The valve was received for analysis on november 23, 2018.Investigation is ongoing.

Event Description

A perceval valve, size 23, was implanted via full sternotomy on (b)(6) 2018.After reportedly proper sizing, the physician implanted the valve, but the valve showed signs of folding on tee when weaning from bypass.When the surgeon re-opened the aorta, folding of the valve was confirmed.The surgeon removed the valve and implanted another valve of the same size with no issue.This added about 20 minutes to the surgical time, with no significant blood loss.It was reported that there were no patient anatomical features or malpositioning were suspected to have contributed to the reported event.

Manufacturer Narrative

Visual and dimensional analysis of the returned device did not reveal any elements of non-conformity.A simulation of the collapsing and deployment procedures were performed.The collapsing procedure was performed with the returned valve and a demonstration accessory kit, and was completed without issue.No problems were encountered during deployment or ballooning of the returned valve in a silicon aortic root.Sealing at the annulus level was confirmed, and the valve remained fixed in the annulus without observing significant anomalies or deformation at the annulus level.A leak test was performed, and no paravalvular leak was observed.The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), and nitinol stent component, as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Based on the performed analyses, the device can reasonably be excluded as a possible contributing factor in the involved event, as no paravalvular leak was identified and the reported issue could not be confirmed.The event cannot be explained by any factor intrinsic to the involved device.Fields were updated to "serious injury" from "malfunction" because the investigations performed did not reveal any device dysfunction.

• 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: 8113799
• MDR Text Key: 129461250
• Report Number: 3004478276-2018-00353
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)211026
• 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: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention