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

Model Number 9600TFX29A

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

Patient Problem Injury (2348)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Udi:  (b)(4).To date, the patient medical records and procedure op notes requested have not been received for review.  at the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards device, or that the use, or miss-use of the device caused, or contributed to the event.A supplemental report will be submitted in accordance with 21 cfr 803.56 when and if additional information becomes available.In this case, the valve is not available for evaluation, however, there was no indication, or allegation that a product deficiency contributed to the event.  the reason for explanting the valve approximately 11 months post tavr is not available at this time.  there is insufficient information to determine if the event was related to a device malfunction.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, approximately 11 months post transcatheter mitral valve in valve procedure with  a 29 mm sapien 3 valve and 29mm surgical valve in the mitral position, the valves were explanted, and a surgical mitral valve was implanted.The cause of the explants is unknown at this time.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10907556
• MDR Text Key: 218920472
• Report Number: 2015691-2020-14730
• Device Sequence Number: 1
• Product Code: NPU
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Date Device Manufactured: 08/02/2019
• 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