MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Heart Block (4444)

Event Date 03/17/2021

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.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 #2.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, an appropriate investigation will be performed.

Event Description

Through implant patient registry, it was learned that a 23mm 8300ab aortic valve was explanted at implant due to incorrectly seated.The explanted valve was replaced with another 23mm 8300ab valve.Per the medical records, the patient presented with severe aortic stenosis and paroxysmal a-fib.The native aortic valve removed and was replaced with a 23mm 8300ab aortic valve; however, the surgeons were unsuccessful at completely covering the aortic annulus.The valve was explanted and replaced with another 23mm 8300ab valve.The valve was inspected and found to be well-seated covering all the annular tissue.Tee demonstrated a properly functioning aortic valve.The patient tolerated the procedure well and was transferred to the icu in stable condition.A dual-chamber pacemaker placement was also performed on pod #2 due to chb.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.

Manufacturer Narrative

H11: corrective data: corrected section: h6 (type of investigation, investigation findings, and investigation conclusions).

• Brand Name: EDWARDS INTUITY ELITE AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11690672
• MDR Text Key: 252666199
• Report Number: 2015691-2021-02557
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194494
• UDI-Public: 00690103194494
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2021
• 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