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

Model Number	2700TFX
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Dizziness (2194); Insufficient Information (4580)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: additional manufacturer narrative: surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.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
Through implant patient registry it was learned that a 23mm 2700tfx aortic valve was explanted after an implant duration of 7 years, 1 month due to unknown reason.The explanted valve was replaced with a 21mm 11500a 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.
Event or Problem Description
Through implant patient registry it was learned that a 23mm 2700tfx aortic valve was explanted after an implant duration of 7 years, 1 month due to stenosis.The patient presented with shortness of breath, chest pain and dizziness.The explanted valve was replaced with a 21mm 11500a valve.The patient was discharged on pod #4.
Additional Manufacturer Narrative
Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (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, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including coronary artery disease (cad) and diabetes mellitus (dm).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17020835
• Report Number: 2015691-2023-13312
• Device Sequence Number: 12550475
• Product Code: DYE
• UDI-Device Identifier: 00690103177183
• UDI-Public: (01)00690103177183(17)170426
• 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: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2017
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 07/10/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/27/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2015
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female