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

Model Number 8300AB

Device Problem Insufficient Information (3190)

Patient Problem Complete Heart Block (2627)

Event Date 11/09/2017

Event Type  Injury  

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 patient¿s post-operative complete heart block was procedure related; there was no evidence the post-op arrhythmias were related to the device or a malfunction of the device.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.The ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.No corrective or preventative actions apply to this case.As there has been no confirmed design defect, manufacturing issue, or inadequacy in the labeling, ifu, or training leading to the complaint, edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required based on the determined control limits, appropriate investigation will be performed.No corrective or preventative actions are required at this time.

Event Description

It was reported that a permanent pacemaker was required for a patient who received a 19 mm aortic valve after an implant duration of 13 days.Her course was notable for post operative dysrhythmia.She initially had a junctional rhythm then developed atrial fibrillation with rvr.She was treated with lopressor and amiodarone and had converted to nsr prior to discharge.She was progressing well at rehab until day of admission when she developed "fluttering in her chest" with shortness of breath and pain.The symptoms resolved but her daughter was worried and had the rehab facility transfer her back to the hospital.She was noted to be bradycardic-mostly sinus but with pauses and junctional rhythm so a pacemaker was placed and medications were adjusted.Per received medical records it was learned that the aortic valve was trilcaflct with heavy calcification in all 3 leaflets and mild-to-moderate calcification in the aortic annulus.At the end of the operation, the bioprosthetic valve was well seated with no valvular or paravalvular leak.The patient was taken to the icu in stable condition.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; lfs-33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7110220
• MDR Text Key: 94570704
• Report Number: 2015691-2017-04241
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2018
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/12/2017
• Date Device Manufactured: 11/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR