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

Model Number 8300AB23

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

Patient Problems Syncope (1610); Arrhythmia (1721); Infarction, Cerebral (1771); Death (1802); Fall (1848); Bone Fracture(s) (1870); Hematoma (1884); Respiratory Failure (2484); Complete Heart Block (2627)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).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.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) 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, appropriate investigation will be performed.The subject device is not available for evaluation, as it remains implanted in the patient.

Event Description

It was reported via the implant patient registry that a patient with a 23mm 8300ab pericardial aortic valve developed complete heart block on pod #2.Per received medical records, the patient tolerated the initial avr and cabg procedure well and without complications.The patient was transferred to the icu in stable condition.On pod #2, he developed chb that converted to nsr.A beta block was initiated, but was discontinued due to hypotension.The patient remained in nsr.On pod #8, the patient had a syncope episode and fell.Cpr was initiated due to heart block, placement of temporary pacing wires were unsuccessful.He was emergently taken to the or and transvenous pacer wires were inserted and thresholds were acceptable.The patient was unable to wean from cpb and tee revealed severely depress rv.Va-ecmo was placement.On pod #9, head ct showed no acute intracranial hemorrhage or mass effect, but nasal fracture, frontal hematoma, and rib fractures.He return to the or and va-ecmo was removed, echo showed moderately depressed rv and lvef 45%, and aortic valve with no pvl.Ep cardiology was consulted for ppm.Due to concern for neurological deficits, repeat head ct was performed on pod #11 which revealed large watershed distribution infarctions in the cerebral hemispheres bilaterally.The patient continued to be supported for chb, acute respiratory failure, aki, and pna.On pod #14, the patient was made dnr with comfort care and subsequently expired on pod #15.

Manufacturer Narrative

Updated: h6.

Manufacturer Narrative

Reference capa-20-00141.

• 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: 10352239
• MDR Text Key: 202706442
• Report Number: 2015691-2020-12881
• 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,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: 8300AB23
• 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; Other; Required Intervention
• Patient Age: 78 YR