MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE, 26MM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

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

Patient Problem Complete Heart Block (2627)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use, conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, deployment of the prosthetic valve, and the overall tavr procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may provide an explanation for these complications of the tavr procedure.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences for complaints-conduction disturbances/ heart block¿, atrioventricular conduction disturbances after tavr are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, tavr may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after tavr are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing tavr or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there is no allegation or indication a device malfunction contributed to this adverse event.The lbbb is likely related to the mechanisms described above.The patient received both an aortic and a mitral sapien valve, therefore the lbbb could be related to one or a combination of both valves placed simultaneously.In addition, procedural factors (implant of aortic thv valve and mitral thv via open heart surgery on cardiopulmonary bypass) may have put the patient at higher risk for the development of complete heart block.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

Upon review of medical records, a 26mm sapien 3 ultra valve was implanted in the native mitral position by sternotomy/transseptal approach.The mitral implant was a success with trivial paravalvular leak.At the time of the sternotomy, the patient's aortic valve was also explanted and a 23mm sapien 3 ultra valve was deployed following explant of the surgical valve.There was also no ew device malfunction nor procedural complication.The aortic implant was a success with no ai or pvl.During the post-operative course, the patient was initially temporarily paced with an underlying rate of 30, developed a lbbb and a-fib, which was cardioverted with success.At discharge on post op day 13 the patient was having pauses <3 seconds, however ep cardiology did not recommend a permanent pacemaker (ppm) at that time.Pod#14, a permanent pacemaker (ppm) was implanted.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE, 26MM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• 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: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10436095
• MDR Text Key: 203843916
• Report Number: 2015691-2020-13230
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2022
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2020
• Date Device Manufactured: 01/29/2020
• 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
• Treatment: EDWARDS COMMANDER DS, ESHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR