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

Model Number 3300TFX

Device Problems Calcified (1077); Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583); Difficult to Open or Close (2921)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve/ring.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Based on the available information, the root cause was likely patient related factors.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that a patient with a 23mm aortic valve implanted for two years, 11 months underwent redo aortic valve replacement due to restricted motion, thrombus, host tissue, undersized valve, and severe stenosis.The patient presented with acute systolic heart failure.A 25mm valve was implanted in replacement.Per medical records, the aortic valve appeared to have some fibrinous tissue growing over the commissures with a lot of thrombus-type material in the annulus in the inner portion of the valves restricting their opening and closing.It also appeared the valve had been slightly undersized the first time.The pathology report shows aortic leaflets to be generally pliable covered with fragments of softened red brown material and sections of the leaflets reveal focal calcifications.The previous valve was a 23mm, and the surgeon was able to put a 25mm valve in without any difficulties.The patient also received a 30mm mitral ring and 32mm tricuspid ring.The patient tolerated this procedure well and was transferred to the icu in stable condition.Echocardiogram showed no mitral regurgitation or systolic anterior motion (sam), no evidence of perivalvular leak, and trace tricuspid regurgitation.The patient was discharged home on pod #8.According to the implant data card, the explant was not due to a deficiency in the device.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated sections d4-expiration date, h4, and h6 (type of investigation).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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESES
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11861437
• MDR Text Key: 251931855
• Report Number: 2015691-2021-03062
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 125