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

Model Number 9350BC25

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

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/29/2022

Event Type  Death  

Event Description

Edwards received notification from our affiliate in (b)(6).As reported, this was a case of an implant of a 29mm sapien 3 valve.After valve pre-dilatation with 25mm ew bav, the patient developed ventricular fibrillation and was hemodynamically unstable.The patient cardioverted and the valve was successfully implanted.A control angiogram showed correct valve position and regular coronary flow.However, the deteriorating hemodynamic condition necessitated the insertion of an ecmo machine, which due to the extreme hypovolemic status of the patient (possibly secondary to gastro intestinal bleeding) was unsuccessful in stabilizing the blood pressure.The patient did not suffer any other injury from the event but was in pulseless electrical activity and could not be revived despite all full resuscitation measures.The patient expired in the hybrid or.As per medical opinion, the root cause of the event could be related to the fact that the patient was initially very unstable due to cardiogenic/hemorrhagic shock.After rapid pacing, cardiac arrest occurred and the patient could not be resuscitated.There were no clear complications related to the valve implant itself.

Manufacturer Narrative

Per the instructions for use (ifu), arrhythmias are known potential adverse events associated with balloon valvuloplasty, the use of local and/or general anesthesia, aortic valve replacement, and the overall thv procedure.Peri-procedural ventricular arrhythmias can be associated with patient and procedural factors such as poor ventricular function, inadequate coronary perfusion, hypovolemia, annular rupture/ aortic dissection, cardiac tamponade, wire and catheter manipulation, and prolonged or repetitive runs of rapid pacing.[during the ta procedure, ventricular arrhythmias can also be associated with apical access and/or significant bleeding from the access site.] these patients can be non-operative or high risk, have complex medical histories and have multiple co-morbidities.They are routinely administered multiple vasoactive drugs during the procedure and are intentionally made hypotensive, utilizing rapid ventricular pacing, to facilitate accurate valve deployment.As a result of these factors, intra-operative arrhythmias and hypotension are not uncommon and are treated with standard therapies, including additional vasoactive drugs or electrical conversion.It is also not uncommon to initiate brief chest compressions or cardiac massage to facilitate the distribution of these vasoactive drugs.If these standard maneuvers are not adequate, initiation of cardiopulmonary bypass (cpb), insertion of iabp, and/or conversion to open surgery may be required.Per the instructions for use (ifu), ventricular fibrillation is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that patient and procedure related factors caused or contributed to this event.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.

• 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: 14806406
• MDR Text Key: 294755206
• Report Number: 2015691-2022-06371
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2022

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: 12/14/2023
• Device Model Number: 9350BC25
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sex: Male