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

Model Number	3000TFX
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned via implant patient registry and investigation that a 3000tfx 25mm valve in pulmonary position was explanted and replaced with a 11500a 29mm after an implant duration of 4 years, 11 months due to stenosis with severe subvalvular stenosis.Per medical records the patient presented with progressive exertional dyspnea.Heart cath showed stenotic pulmonic valve.She underwent redo-pvr with rvot reconstruction with bovine pericardium, and cabg x1.The previous dacron graft had severe subvalvular stenosis, it was open and the 25mm valve came out pretty easily.The graft was cleaned of pannus and fibrous tissue.A 29mm 11500a was then sewn into the previous graft.After weaning off cpb, there was good prosthetic valve function and biventricular function, and she was transferred to the icu.On pod 5, the patient was discharged in stable condition on aspirin and coumadin (for mechanical avr).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.
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 device was not returned for evaluation, as device availability is unknown.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.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 related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including implant position and patient's age at time of implant.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19758032
• Report Number: 2015691-2024-05387
• Device Sequence Number: 9016029
• Product Code: DYE
• UDI-Device Identifier: 00690103163667
• UDI-Public: (01)00690103163667(17)221029
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 10/29/2022
• Device Model Number: 3000TFX
• 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: 06/23/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2018
• 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: 22 YR
• Patient Sex: Female