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

Model Number PVS27

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Aortic Valve Stenosis (1717); Thrombosis (2100)

Event Type  Death  

Event Description

The manufacturer was notified that a patient received a perceval pvs27 in 2018.In (b)(6) of 2020 the patient was identified to potential thrombosis with a high gradient.They were indicated for a redo avr and cabg on (b)(6) 2020.On (b)(6) 2020 the patient had taken/been given plavix and was being rescheduled for monday.The patient condition worsened and was taken to the operating room.The patient was given chest compression's on the operating room table as the staff tried to prep them and cannulate femoral.Patient heart rate was established via heart compression's.The chest was opened and the site attempted to resolve bleeding issues and adhesion's.The aorta was not opened.The patient passed away and the valve was never explanted.No further details were received.

Manufacturer Narrative

The manufacturer made several attempts to follow-up for further information related to the specific event details and no further information was received.At this time since no further information regarding the root cause is available and the device was not explanted no further investigations can be performed.Because of the limited information surrounding the device functionality over time, patient factors, and correlation between the thrombosis and the adverse event the root cause cannot be established at this time.However, should additional information be provided, the manufacturer will re-assess the event and take further investigative action as applicable.It should be noted the device history record confirmed the device met all required standards at the time of manufacture and release.

Manufacturer Narrative

The manufacturer determined the device serial number through the patient tracking database.The sn has been included in section d.The manufacturing and material records for the perceval heart valve, model #icv1211 , s/n # (b)(6), 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 #icv1211) perceval heart valve at the time of manufacture and release.

• 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: 10486087
• MDR Text Key: 205451412
• Report Number: 1718850-2020-01127
• 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,Followup
• Report Date: 08/06/2020,10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2021
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2020
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death