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

Model Number 3300TFXJ25

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Perivalvular Leak (1457); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/18/2023

Event Type  Injury  

Event Description

Edwards received information that a patient with a 25mm 3300tfx pericardial aortic valve underwent a valve-in-valve procedure due to mild aortic regurgitation secondary to structural valve deterioration after an implant duration of unknown period.A symptom of heart failure nyha class iii, and dyspnea on exertion was seen.A 26mm sapien 3 transcatheter valve was implanted in replacement.The patient status was reported as "recovered.".

Manufacturer Narrative

Additional manufacturer narrative: 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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device history record (dhr) could not be reviewed, as the device serial number was not provided.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.H11 corrected data: section h6 type of investigation.

Manufacturer Narrative

Manufacturer narrative updated sections: a2 date of birth, b3, b5, b7, d6a, g3, g6, and h6 device code(s).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 valve's 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.H11 corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Edwards received information that a patient with a 25mm 3300tfx pericardial aortic valve underwent a valve-in-valve procedure due to aortic stenosis, mild aortic regurgitation and mild paravalvular leak secondary to calcification and structural valve deterioration after an implant duration of ten (10) years and two (2) months.A symptom of heart failure nyha class iii, and dyspnea on exertion was seen.A 26mm sapien 3 transcatheter valve was implanted in replacement.The patient status was reported as "recovered".The patient was discharged from the hospital on pod 4.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16327108
• MDR Text Key: 309079752
• Report Number: 2015691-2023-10690
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2023

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
• Device Model Number: 3300TFXJ25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/24/2023; 12/15/2023
• Supplement Dates FDA Received: 03/24/2023; 12/28/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 62 KG