MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Death (1802); Mitral Valve Stenosis (1965); Injury (2348); Complete Heart Block (2627); No Code Available (3191)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The clinical observation was confirmed.Peri-procedural arrhythmias, heart block, and other conduction disturbances are common in patients with underlying cardiovascular disease and/or conduction abnormalities.They can be exacerbated with standard perioperative medications, anesthesia, and/or instrumentation of the heart.Temporary pacemakers are inserted in all patients undergoing aortic valve replacement (avr).It is not uncommon for patients to have short term/reversible periods of heart block or arrhythmias following the procedure while their heart recovers from cardiopulmonary bypass.In many cases, the temporary pm is left in the patient for a short time following the procedure and then subsequently removed prior to discharge.Following surgical aortic valve replacement (avr), new-onset bundle branch block has been reported in 16% to 32% of patients and the need for permanent pacemakers in 3% to 8% of patients.The reason for post-operative av block after surgical avr is related to injury to the cardiac conduction system during surgical excision of the adjacent diseased valve and annular tissue.The close anatomical relationship between the aortic valvular complex and the branching atrioventricular bundle explains the possible development of conduction abnormalities following prosthetic aortic valve procedures.The cause of the event remains undetermined.If additional information is received a supplemental mdr will be submitted.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.In this case, edwards implant patient registry received information a patient with a 23mm aortic valve implanted two (2) days underwent permanent pacemaker implant due to complete atrioventricular block.Patient was admitted to hospital with critical symptomatic aortic valve stenosis and severe mitral stenosis.Patient underwent aortic valve replacement with a 23mm aortic valve, mitral valve replacement with a 29mm mitral valve, and aortic root enlargement with a hemashield patch.Patient was placed on intra-aortic balloon pump.Patient was taken off bypass and it was noted the right ventricle was failing somewhat secondary to patient's pulmonary hypertension and possibly protamine reaction.Steroids, epinephrine, and nitric oxide were given.Patient was able to come off bypass and stay off bypass.Post-operative echo demonstrated good function of both the mitral and aortic valves with no abnormalities and no evidence of any paravalvular leak (pvl).The patient was transferred to the cvr unit in stable condition.Patient had complete atrioventricular block and underwent implanted of permanent pacemaker on post-operative day two (2).The patient also had to have a tracheostomy because the patient could not be weaned from ventilator.The patient also developed acute kidney injury, put on hemodialysis.The patient became hypotensive on post-operative day 14.The patient had a rhythm but no pulse.Code was performed for 30 minutes but patient did not have return of blood pressure or pulse, patient declared deceased.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa: 20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10230955
• MDR Text Key: 199902689
• Report Number: 2015691-2020-12419
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036/S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR