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

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

Patient Problems Arrhythmia (1721); Complete Heart Block (2627)

Event Date 12/01/2012

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.(ref: (b)(4)) 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.  the device was not returned for evaluation, as it remains implanted.The root cause of the reported event cannot be conclusively determined; however, it appears that this event was likely due to patient and/or procedural related factors.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Through review of medical article "early outcomes with rapid-deployment vs stented biological valves: a propensity-match analysis" authors michel carrier, et al it was learnt about a propensity-matched study aimed to compare clinical and echographic outcomes between patients undergoing rapid-deployment aortic valve replacement (rdavr) compared with stented biological aortic valve replacement (savr), with or without concomitant procedures.Between 2012 and 2015, 61 consecutive patients (age 70 ± 7 years, european system for cardiac operative risk evaluation [euroscore] ii 2.1%) underwent aortic valve replacement with intuity prosthesis (edwards, (b)(4)) at the montreal heart institute within the context of this article the following events occurred perioperatively were identified as pertaining to the edwards intuity valves: one case of av block complete requiring implantation of permanent pacemaker.

Manufacturer Narrative

Reference capa-20-00141.

• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9331552
• MDR Text Key: 168225076
• Report Number: 2015691-2019-04267
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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