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

Model Number PVS25

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Due to the limited information available on the reason for the re-intervention, on the patient's impact and on the relationship with the device, the event is being reported in a conservative manner.The manufacturer is following up to obtain further information.Device not explanted.

Event Description

The manufacturer was informed that a tavi procedure is planned for a patient that has a perceval pvs25 in aortic position.No other information is currently available.

Manufacturer Narrative

Despite the attempts to retrieve further information on the event, no additional data has been received to date.Since the serial number was not provided and the device remains implanted in the patient, no further investigation can be performed.If new information is received, the case will be re-assessed and appropriate investigative action will be taken.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8224555
• MDR Text Key: 132343079
• Report Number: 3004478276-2019-00112
• Device Sequence Number: 1
• Product Code: LWR
• 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: 02/11/2019

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: Health Professional
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other