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

Model Number 9600TFX20

Device Problem Gradient Increase (1270)

Patient Problem Thrombosis (2100)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4); investigation is ongoing.This individual report provides data received from the thv/tvt registry.

Event Description

As reported by the edwards european affiliate, 10 months after implantation of a 20mm sapien 3 valve, the patient began to suffer from severe angina.Cardiac echocardiography showed aov peak velocity 430 cm/s, aov peak gradient 74 mmhg and aov mean gradient of 39 mmhg.Patient was hospitalized due to chest pain.Treatment involved anticoagulation therapy, as physician suspects valve thrombosis as root cause of aortic valve stenosis.A viv procedure was performed with a self-expandable non-edwards valve.Thrombosis was confirmed as the root cause and the patient was in good condition and stable.

Manufacturer Narrative

Citation: hong, n.C., et al.''transcatheter aortic valve replacement with anterograde guide wire through atrial septum in 2 patients with severe aortic stenosis post transcatheter or surgical aortic valve replacement.'' zhonghua xin xue guan bing za zhi 50.5 (2022): 509-511.Corrected b.7 and d6a based on information discovered in the article referenced above.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11083316
• MDR Text Key: 224386931
• Report Number: 2015691-2020-15303
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Model Number: 9600TFX20
• Device Lot Number: 5731788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Date Device Manufactured: 08/29/2017
• 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 Age: 73 YR