MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX

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

Patient Problem Retroperitoneal Hemorrhage (4483)

Event Date 02/28/2024

Event Type  Death  

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 (thv) procedure.A procedural or post procedural bleed/ hemorrhage without an obvious source of bleeding is a rare but potentially life-threatening complication of coronary/cardiac interventional procedures and tends to occur more frequently in the presence of more aggressive anticoagulation regimens.Possible sources include puncture of the femoral artery above the inguinal ligament and above the inferior epigastric artery, allowing the resultant bleeding to extend into the retroperitoneal space, or inadvertent trauma or perforation of the annular structure or ventricles during the procedure.This type of bleeding may not be recognized until the post procedural period.Edwards extensively trains physicians before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that a more proximal access site could have 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

Event Description

As reported to the implant patient registry (ipr), 1-day post-implant of a 29 mm sapien 3 valve in the aortic position, the patient expired.Follow up indicated that the patient expired due to excessive blood loss from a retroperitoneal bleed as confirmed by the cardiothoracic surgeon who was in the procedure.Additional information received noted that the sheath was placed on the left femoral, which is the same side as the retroperitoneal bleed.The bleeding event was caused by a more proximal access site on the same side the esheath was used, and it is possible the esheath could have contributed to the event.The patient received blood products and several covered stents were placed at the site of injury using the contralateral side.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: 19002584
• MDR Text Key: 338882059
• Report Number: 2015691-2024-02430
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Death; Required Intervention
• Patient Sex: Male