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

Model Number UNKNOWN

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problems Aortic Regurgitation (1716); Death (1802)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Based on the present information there are no device related malfunctions the device dislodgement was resolved and no issues were identified after re-implanting the device.Based on this it is reasonable to attribute the original dislodgement to user error or procedural issues.The manufacturer is reporting an off label action which may have increased the risk to the patient.Per the perceval ifu 850-07ls202.Directions for use - "warning: a removed perceval s prosthesis must not be reimplanted, because its integrity is no longer ensured." at this time the reported off-label action is not suspected to have caused any harm to the patient as the patient death was reportedly not valve related.Because there is no indication of device related malfunctions or inefficiencies at this time the manufacturer is submitting an initial and final report and will not perform any further investigations related to this case.No indication of explant.

Event Description

On (b)(6) 2019 a patient received an avr, plus 1 graft, after presenting to the hospital with cardiac arrest with low ejection fration (ef) and atrial fibrillation (af).The manufacturer was notified of the following.A perceval s sutureless aortic heart was implanted, all visual checks were completed, no pinwheeling or over-sizing noted.Patient was taken off pump and the site noticed a paravalvular leak.After reopening they noticed the cage was higher and had slightly migrated.The valve was explanted and recollapsed.The site re-positioned the perceval in the annulus.On visual inspection the cage did look lower after second implant.The patient came off pump successfully.It was reported that the following day the patient had a cardiac arrest.They re-operated to inspect, but the patient suffered cardiac arrest and passed away.It was deemed not valve related and most likely due to air.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 n fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 9390481
• MDR Text Key: 168457339
• Report Number: 3004478276-2019-00317
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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