MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON; BALLOON AORTIC VALVULOPLASTY

Model Number 9350BC20JP

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

Patient Problem Heart Block (4444)

Event Date 05/19/2022

Event Type  Injury  

Event Description

Before valve deployment, balloon aortic valvuloplasty (bav) was performed with a 20 mm edwards transfemoral balloon catheter.Immediately after bav, complete atrioventricular block (cavb) temporarily developed.During a transfemoral tavr for the native aortic position, a 23mm sapien 3 valve was deployed between 80:20 and 90:10 aortic/ventricular position with 2ml less contrast solution than nominal volume as intended.The deployment position was satisfactory.Although cavb was temporarily noted immediately after valve deployment, the patient had first degree av block in the subsequent course after an e-sheath removal.A temporary pacemaker was removed on postoperative day one.On the early morning of post op day two, cavb developed and a temporary pacemaker was inserted again.Because the patient was pacing-dependent during sleep, a permanent pacemaker implantation was performed on post op day five.

Manufacturer Narrative

Per the instructions for use (ifu), conduction system defects (heart block), arrhythmias and conduction system defects that may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, bioprosthetic heart valves, and the thv 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 explain these complications of the thv procedure.According to the literature review, and as documented in a clinical technical summary written by edwards lifesciences , atrioventricular conduction disturbances after thv 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, thv may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after thv are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing thv or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results are inconclusive as patient and procedural factors were not provided; however, the event could be related to the mechanisms described above.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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 monthly, 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.Device was discarded.

• Brand Name: EDWARDS TRANSFEMORAL BALLOON
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14738498
• MDR Text Key: 294938374
• Report Number: 2015691-2022-06251
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00690103195088
• UDI-Public: (01)00690103195088(17)231119(10)64096793
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2022

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: 11/19/2023
• Device Model Number: 9350BC20JP
• Device Lot Number: 64096793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 55 KG