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

Model Number 8300AB

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

Patient Problem Complete Heart Block (2627)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4).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.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.A manufacturing related issue was not identified.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received information that the third degree atrioventricular block was detected after six (6) days form the implantation surgery of this 27mm valve.This device was originally implanted to correct aortic stenosis due to severe calcification.After an implant duration of approximately three (3) months, pacemaker was implanted to the patient.The patient status was reported as ¿recovering¿.The device was not returned for evaluation as it remained implanted.Multiple cardiac surgical procedure: coronary artery bypass grafting at implant.The surgeon commented that this event was device related as this event occurred after implantation surgery.

Manufacturer Narrative

Corrected data- updated h6 (result).

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10121441
• MDR Text Key: 194109408
• Report Number: 2015691-2020-12068
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72