Model Number 3300TFX |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Difficult to Open or Close (2921); Insufficient Information (3190); Device Stenosis (4066)
|
Patient Problems
Angina (1710); Chest Pain (1776); Insufficient Information (4580)
|
Event Date 09/07/2023 |
Event Type
Injury
|
Event Description
|
Through implant patient registry it was learned a patient with a 23mm 3300tfx aortic valve implanted five (5) years, three (3) months, underwent valve-in-valve procedure due to unknown reasons.Tavr was performed with a 23mm 9755rsl transcatheter valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.
|
|
Manufacturer Narrative
|
The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
|
|
Manufacturer Narrative
|
The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The most likely cause of the stenosis and frozen leaflets is patient factors, including coronary artery disease (cad), hyperlipidemia and diabetes mellitus (dm).
|
|
Event Description
|
Through implant patient registry and investigation it was learned a patient with a 23mm 3300tfx aortic valve implanted five (5) years, three months, underwent valve-in-valve procedure due to two frozen leaflets, critical aortic stenosis and patient prosthetic mismatch.Patient presented with unstable angina and chest pain.Tavr was performed with a 23mm 9755rsl transcatheter valve.The patient was stable at the end of the procedure and was discharged on pod# 1.
|
|
Search Alerts/Recalls
|