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

Model Number 9350BC25JP

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

Patient Problem Cardiac Perforation (2513)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries, including perforation or dissection of vessels, ventricle, myocardium or valvular structures, are potential adverse events associated with standard cardiac catheterization, balloon valvuloplasty and the transcatheter aortic valve replacement (tavr) procedure.There are several potential etiologies for ventricular perforation during a tavr procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Per the instructions for use (ifu), cardiac perforation 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 these adverse events.Investigation results suggest/indicate procedural factors (possible straight wire perforation) caused or contributed to these events.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

Edwards received notification from our affiliate in japan.As reported, a patient underwent a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 29 mm sapien 3 valve.During balloon aortic valvuloplasty (bav) with a 16 mm balloon and inserting balloon catheter at ascending aorta, hypotension occurred.Echo revealed pericardial effusion.Balloon catheter and guide wire were withdrawn, and then pericardiocentesis was performed.However, pericardial effusion did not decrease.Thoracotomy was performed which revealed ventricular perforation (apical).Hemostasis was achieved surgically and then the tavr was performed.The procedure was completed successfully.The patient was recovering, and was scheduled to discharge on pod 15.The operator commented that although it was not noticed during the procedure, the straight wire might have led to a perforation during valve crossing.The event was related to the procedure, but not the device.

• 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: 14962645
• MDR Text Key: 295598700
• Report Number: 2015691-2022-06701
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00690103195101
• UDI-Public: (01)00690103195101(17)230318(10)63698172
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: 9350BC25JP
• Device Catalogue Number: N/A
• Device Lot Number: 63698172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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: 85 YR
• Patient Sex: Male