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

Model Number	2700TFX
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that a 23mm 2700tfx valve was explanted after an implant duration of 3 years, 2 months due to pvl.The patient underwent bentall procedure to treat aortic aneurysm.The explanted valve was replaced with a 21mm 11500a valve.The patient was discharged home on pod#9.The patient is a 57-years-old female with a history of hypertension, hyperlipidemia, asthma, diabetes mellitus, atrial fibrillation on anticoagulation, complete heart block s/p ppm, vocal cord dysfunction, hypothyroidism, endocarditis strep viridans s/p redo avr/debridement of aortic annulus drainage of abscess and placement of a #23 mm bovine pericardial patch (5/7/2019), ligation of celiac artery pseudoaneurysm (2019) and dilated ascending aorta found to have pseudoaneurysm of ascending aorta.
Additional Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus or improper seating.The most common reason for pvl is inadequate debridement of a calcified annulus and is not a result of device malfunction.The most likely cause is patient factors, including the patient's aortic root pseudoaneurysm and ascending and proximal arch aneurysm.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards lifesciences; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502371
• MDR Report Key: 15277599
• Report Number: 2015691-2022-07465
• Device Sequence Number: 17874469
• Product Code: DYE
• UDI-Device Identifier: 00690103194036
• UDI-Public: (01)00690103194036(17)221015
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 10/15/2022
• Device Model Number: 2700TFX
• Device Catalogue Number: 2700TFX23MM
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/03/2022
• Date Device Manufactured: 10/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female