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

Model Number 9750TFX20A

Device Problem Perivalvular Leak (1457)

Patient Problem Hemolysis (1886)

Event Date 10/26/2022

Event Type  Injury  

Event Description

As reported, approximately 1 year, 7 months post tf tavr the patient was admitted with what is probable severe para-valvular leak causing hemolysis.The patient received an 8mm avp ii vascular plug thus resolving the pv leak.The patient left the room in stable condition.

Manufacturer Narrative

Investigation is ongoing.Valve remains implanted.

Manufacturer Narrative

Updated h.6 codes.The device was not returned for evaluation.A dhr review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.During manufacturing of the sapien 3 ultra transcatheter heart valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The ifu was reviewed.Long-term durability has not been established for the valve.Regular medical follow-up is advised to evaluate valve performance.Paravalvular or transvalvular leak, valve regurgitation, and hemolysis are all listed as potential risks associated with the use of the valve, delivery system, and/or accessories.No ifu/training deficiencies were identified.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.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 the failure mode is not required at this time.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.The paravalvular leak was unable to be confirmed due to unavailable of relevant medical record/ imagery.A review of the dhr revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.A review of ifu/training materials revealed no deficiencies.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement procedure.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post-deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.Due to limited information, a definitive root cause for severe pvl approximately 1 year and 7 months post tavr was unable to be determined at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 15784914
• MDR Text Key: 303557589
• Report Number: 2015691-2022-09225
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: 9750TFX20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2020
• 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 Sex: Female