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

Model Number 9350BC23JP

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), hypotension is a potential adverse events associated with the overall thv procedure, including vascular and apical access, use of angiography, balloon valvuloplasty, use of conscious sedation and/or general anesthesia, and the bio-prosthesis implantation.Balloon valvuloplasty is performed to open 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 may require hemodynamic support if they are symptomatic to new regurgitation and significant hypotension may result.Intra-operative hypotension during the thv procedure 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.If these standard maneuvers are performed during the procedure and are not effective in stabilizing the patient's hemodynamics, additional support (cpb, ecmo, iabp, etc.) may be needed.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest the performance of the bav caused the reported acute aortic regurgitation and subsequent hypotension, which was treated with cardiac massage and pcps.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 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.

Event Description

The patient underwent transfemoral transcatheter aortic valve replacement (tavr) for the native aortic position using a 23mm sapien 3 ultra resilia valve.During balloon aortic valvuloplasty (bav) with a 23mm edwards balloon catheter, the balloon slipped before complete expansion twice.After the second bav, blood pressure remained stable even after rapid pacing.However, during the third bav, fluoroscopy revealed upward displacement of the calcified valve leaflets.This finding was also confirmed by echocardiography.Following the third bav, blood pressure was 30/20 mmhg, and echocardiography showed reduced cardiac contraction.The cause was considered to be acute aortic regurgitation (ar), for which adrenaline was administered and valve crimping was performed.Due to limited space in the sov observed on angiography during bav, a 23mm valve was selected.Despite adrenaline administration, cardiac contraction was poor and blood pressure was 31/21 mmhg.The patient was placed on ecmo, and gradual improvement in cardiac contraction was observed.However, ventricular fibrillation (vf) developed.After direct current (dc) shock was given 10 times and antiarrhythmic drug(s) was administered, the vf returned to pacing rhythm.Paravalvular leak (pvl) was trivial, there was no pericardial effusion, and coronary flow was satisfactory.Cardiac contraction was gradually improved, and blood pressure stabilized.Thus, ecmo was removed, and the patient was transferred to icu under intubation.Per medical opinion, hemodynamic collapsed due to due to acute ar.Currently, the patient remains unconscious and is receiving treatment.The valve is functioning without problems.

• Brand Name: EDWARDS TRANSFEMORAL BALLOON CATHETER
• Type of Device: BALLOON AORTIC VALVUPLASTY
• 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: 19009356
• MDR Text Key: 338978613
• Report Number: 2015691-2024-02465
• Device Sequence Number: 1
• Product Code: OZT
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9350BC23JP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 91 YR
• Patient Sex: Male
• Patient Weight: 63 KG