MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	2800TFX
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through patient support center and medical records, a patient with a 25mm 2800tfx aortic valve underwent a valve-in-valve procedure after an implant duration of six (6) years, nine (9) months, due to calcification, severe mitral regurgitation and severe stenosis.Patient presented with v.Tach cardiac arrest, severe cardiomyopathy, and acute congestive heart failure.Tavr was performed with a 29mm non-edwards transcatheter valve.Patient was extubated successfully in or and transferred to micu.Patient was discharged on pod# 3.Patient made no allegation against the 2800tfx valve.Per medical records, the patient presented with v.Tach cardiac arrest, severe cardiomyopathy, and acute congestive heart failure.Tavr was performed with a 29mm non-edwards transcatheter valve.Patient was extubated successfully in or and transferred to micu.Patient was discharged on pod# 3.
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it remains implanted.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.
Additional Manufacturer Narrative
Corrected b5 and h6.
Event or Problem Description
It was learned through patient support center and medical records that a patient with a 25mm 2800tfx aortic valve underwent a valve-in-valve procedure after an implant duration of six (6) years, nine (9) months, due to calcification.Patient presented with acute congestive heart failure.Tavr was performed with a 29mm non-edwards transcatheter valve.Patient was extubated successfully in or and transferred to micu.Patient was discharged on pod# 3.Patient made no allegation against the 2800tfx valve.Per medical records, the patient presented with acute congestive heart failure and severe non-ischemic cardiomyopathy.Workup showed severe symptomatic bioprosthetic aortic valve stenosis and moderate native mitral regurgitation.While in the hospital, the patient had a witnessed ventricular tachycardia ended with cardiac arrest with successful rocs.The patient underwent a valve-in-valve procedure under general anesthesia.Tavr was performed with a 29mm non-edwards transcatheter valve.The surgical valve was fractured using a 10 x 40 mm balloon.Post rapid pacing, the patient developed another episode of ventricular tachycardia requiring dccv with restoration of sinus rhythm.Post deployment aortography and tee revealed absence of any meaningful pvl with adequate transcatheter valve position and stability.Patient was extubated successfully in or and was transferred to micu.Patient was discharged on pod# 3.
Additional 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.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valves hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19332857
• Report Number: 2015691-2024-03631
• Device Sequence Number: 2972174
• Product Code: DYE
• UDI-Device Identifier: 00690103177251
• UDI-Public: (01)00690103177251(17)161208
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2016
• Device Model Number: 2800TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 06/18/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/14/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male