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

Model Number 8300AB25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

Additional 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.In this case, the patient required a permanent pacemaker within 30 days of implant of an intuity elite valve.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.The device history record (dhr) could not be reviewed, as the device serial number was not provided.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.The subject device is not available for evaluation, as it remains implanted in the patient.

Event Description

Edwards received information that a (b)(6) y-o patient experienced an arrhythmia event after the implantation of a intuity valve model 8300ab25.As reported, a complete avb occurred after surgery.A permanent pacemaker was implanted on pod # 5.The patient was reported as to be well and discharged.As reported, initial indication for replacement was aortic stenosis.The surgeon was highly experienced with intuity valves.Patient did not have pre-operative history of arrhythmia and/or conduction disturbances.As reported, normal debridement of the annulus was performed prior to device implant at infraannular non coronary level and supraannular on the rest of the annulus.The result was a concentric and soft annulus.

Manufacturer Narrative

Updated: b4, b5, d4, g4, h6, h10.H10: additional manufacturer narrative: the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

Event Description

Edwards received information that a 75-y-o patient experienced an arrhythmia event after the implantation of a intuity valve model 8300ab25.As reported, a complete avb occurred after surgery.A permanent pacemaker was implanted on pod # 5.The patient was reported as to be well and discharged.As reported, initial indication for replacement was aortic stenosis.The surgeon was highly experienced with intuity valves.Patient did not have pre-operative history of arrhythmia and/or conduction disturbances.As reported, normal debridement of the annulus was performed prior to device implant at infraannular non coronary level and supraannular on the rest of the annulus.The result was a concentric and soft annulus.

• 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: 11215885
• MDR Text Key: 230759681
• Report Number: 2015691-2021-00226
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR