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

Model Number 9600TFX29A

Device Problem Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Injury (2348)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Valve in valve is performed as an intervention for severe or clinically significant pvl, central leak, or due to malposition.This intervention is performed to treat serious injury and/or prevent permanent impairment.Due to the limited information available, the reason for this valve in valve procedure cannot be determined.It is possible that, in addition to the procedure itself, unknown patient factors may have contributed to the event.In this case, at the time of this report, there is no indication or allegation that a product deficiency or device malfunction contributed to the event.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.A supplemental report will be submitted in accordance with 21 cfr 803.56 when and if additional information becomes available.

Event Description

As reported by implant patient registry through receipt of an patient implant data card, approximately 1 year and 4 months post implant of a 29 mm sapien 3 valve tavr procedure via transfemoral approach, the patient's underwent a valve in valve procedure.A 29mm sapien 3 valve was implanted into the existing 29mm sapien 3 valve.The cause of the valve in valve procedure is unknown at this time.

Manufacturer Narrative

Correction: f10, b5 - additional information was received from hospital.   per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.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.In this case, the patient underwent a valve in valve procedure due to severe aortic insufficiency (ai) following the first tavr procedure.It is unknown what type of ai the patient experienced.There was no allegation or indication a product deficiency contributed to this adverse event.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

As reported by implant patient registry through receipt of an implant card, the patient had a 29 mm sapien valve implanted in the aortic position via transfemoral approach.Approximately 1 years and 4 months post implant, the patient's underwent a valve in valve procedure and the 29mm sapien 3 valve was implanted into another 29mm sapien 3 valve. it was initially reported that the patient underwent a valve in valve procedure for unknown reasons.However, per follow up with the hospital's valve clinic coordinator nurse, the patient received a second valve due to severe aortic insufficiency (paravalvular) following the first tavr procedure.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11144037
• MDR Text Key: 226043473
• Report Number: 2015691-2021-00103
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR