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

Model Number PVS21

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/23/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 a patient was intended to receive a perceval pvs21 sutureless aortic heart valve as part of the (b)(6) study.The manufacturer was notified of an intra-operative serious adverse event - paravalvular leakage due to migration of the device.The site reported the device was explanted as a result of the issue.A new perceval pvs 21.

Manufacturer Narrative

This case is a duplicate of case # 2019-03655 (closed case) ref mw # 005683 (initial-(b)(6)) and mw 006053 (fu-(b)(6)).Because this case is a duplicate, no further investigation or reporting will be provided.Please refer to mw # 005683 (initial-(b)(6)) and mw 006053 (fu-(b)(6)).

• 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: 9497969
• MDR Text Key: 176231377
• Report Number: 1718850-2019-01214
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/22/2019,03/23/2020

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: PVS21
• Device Catalogue Number: ICV1208
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 49