MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB19

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

Patient Problems Arrhythmia (1721); Complete Heart Block (2627); No Code Available (3191)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

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.Arrhythmias and conduction disturbances are also common after surgical repair or replacement of the tricuspid and mitral valves due to the proximity of the conduction pathways.In this case, the patient developed complete heart block post operatively.The patient required a permanent pacemaker placement on pod #4.The patient was discharged on pod #14.The root cause of this event cannot be determined with the available information.However, there is no information suggesting there was any device malfunction and/or deficiency.This event was likely due to patient and/or procedural related factors.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that complete atrioventricular block was detected after an implantation surgery of this 19mm intuity valve.This device was originally implanted for aortic valve replacement to correct aortic stenosis.After implant, complete atrioventricular block was detected, and the pacemaker was implanted.The patient status was reported as ¿recovered¿.The device was not returned for evaluation as it remained implanted.

Manufacturer Narrative

Updated: a1, a2, a3, a4, b5, b7, h6.

Event Description

Edwards received information that sick sinus syndrome was detected on the following day of the implantation surgery of this 19mm intuity valve.This device was originally implanted to correct aortic stenosis due to moderate calcification.On postoperative day nine (9), permanent pacemaker was implanted for the patient.The patient status was reported as ¿recovered¿.The device was not returned for evaluation as it remained implanted.Patient medical history: angina (class ii), coronary artery disease, peripheral artery disease, hypertension, atrial fibrillation, cerebrovascular, diabetes, dementia, attack of unconsciousness.

Manufacturer Narrative

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

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9397360
• MDR Text Key: 169031101
• Report Number: 2015691-2019-04448
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Model Number: 8300AB19
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 53