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

Model Number 9600TFX23A

Device Problems Calcified (1077); Material Deformation (2976)

Patient Problem Dyspnea (1816)

Event Date 04/11/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by the field clinical specialist (fcs), 4 years, 2 months, and 26 days post-implant of a 23 mm sapien 3 valve in the aortic position, the patients existing sapien 3 was somewhat "crushed" from an unknown force.There is no record of cpr that would have crushed the valve.The patient was experiencing dyspnea and unable to walk any distance.The gradient before the valve in valve was 150mm by pigtail catheter and reduced to 7mm post implant of the valve-in-valve with the 23mm s3ultra resilia.The patient was post-dilated with 23mm true balloon.Imagery was provided by the complaint site and the following observations were made: valve frame was deformed.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from additional response from a medical record review.The following sections of this report has been updated: update to b4, b5, b7, g3, g6, h2, h6, h10.Investigation is ongoing.

Event Description

As reported by the field clinical specialist (fcs), 4 years, 2 months, and 26 days post-implant of a 23 mm sapien 3 valve in the aortic position, the patients existing sapien 3 was somewhat "crushed" from an unknown force.There is no record of cpr that would have crushed the valve.The patient was experiencing dyspnea and unable to walk any distance.The gradient before the valve in valve was 150mm by pigtail catheter and reduced to 7mm post implant of the valve-in-valve with the 23mm s3ultra resilia.The patient was post-dilated with 23mm true balloon.Imagery was provided by the complaint site and the following observations were made: valve frame was deformed.After reviewing the medical records provided, the patient had the implantation of a 23mm s3ur inside the 23mm s3 valve as valve-in-valve.The bioprosthetic aortic valve frame was partially crushed by an unknown cause, which resulted in severe bioprosthetic aortic valve stenosis, and the patient had to be urgently admitted to the ed with worsening chest pain and shortness of breath.On exam, patient was in respiratory distress and complains of (c/o) active chest pain.The patient was found to be in tachycardia, hypotensive and diaphoretic and required bipap due to hypoxia.

• 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: 19172445
• MDR Text Key: 340916445
• Report Number: 2015691-2024-03101
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)210914
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2019
• 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: 56 YR
• Patient Sex: Male