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

Model Number 9350BC20

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

Patient Problem Cardiac Arrest (1762)

Event Date 04/29/2022

Event Type  Death  

Event Description

As reported by an edwards sweden affiliate, during a transfemoral tavr procedure with a 23 mm sapien 3 valve, strong resistance was felt during insertion of the delivery system and valve into the esheath.When the delivery system exited the distal part of the esheath, a small sound could be heard and felt in the delivery system handle as it 'snapped' in the valve.Soon after the valve was inserted, the patient went into cardiac arrest.However, per report, the cardiac arrest was not associated with the valve insertion, but aortic insufficiency induced by the bav device.Prior to valve alignment, the balloon was noted to have an abnormal 'spiral' below the balloon, which was observed on cine images.The delivery system and valve was then withdrawn.After the valve was removed, cpr was initiated and continued until a new valve was prepared, inserted, and deployed.The patient was not able to be resuscitated after the valve was deployed, and passed away.

Manufacturer Narrative

Per the instructions for use (ifu), cardiac arrest is a known potential adverse event associated with balloon valvuloplasty, the use of local and/or general anesthesia, cardiac valve replacement with the thv procedure.Balloon valvuloplasty is performed to open up the stenotic valve prior to thv deployment.Regurgitation after bav is not uncommon and may vary in severity.Typically, this is resolved by deployment of the new valve.Patients undergoing the tavr procedure can be non-operative or high risk, have complex medical histories and multiple co-morbidities.These patients may require hemodynamic support if they are symptomatic to new regurgitation and significant hypotension may result.Intra-operative hypotension is very common during the tavr procedure and is treated with standard therapies, including vasoactive drugs.It is not uncommon to initiate brief chest compressions or cardiac massage to facilitate distribution of these vasoactive drugs.Cardiac arrest occurs when a major cardiovascular, respiratory, or metabolic event results in the inability of cardiac muscle to generate sufficient force in response to electrical depolarization.It may be caused by a profound cardiovascular insult.Examples include severe prolonged hypoxia or acidosis, extreme hypovolemia, flow-restricting pulmonary embolus, cardiac tamponade, thrombosis (coronary or pulmonary).These events may be related to the edwards device if it is associated with cardiac tamponade, annular rupture, or other edwards's device related bleed.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate procedural or patient factors not provided may have caused or contributed to the event.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.

• Brand Name: EDWARDS TRANSFEMORAL BALLOON CATHETER
• 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: 14595408
• MDR Text Key: 293291951
• Report Number: 2015691-2022-06022
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K140241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: 9350BC20
• Device Catalogue Number: 9350BC20A
• Device Lot Number: 63946581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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; Death