MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS; TISSUE, HEART-VALVE

Model Number 11000A

Device Problems Degraded (1153); Structural Problem (2506)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Pulmonary Regurgitation (2023); Stenosis (2263)

Event Date 06/17/2017

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) 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.Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.There can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific 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, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.A manufacturing related issue was not identified.A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that at the three year follow-up visit of a patient with a 21mm pericardial aortic valve in the pulmonary position, echocardiogram showed prosthetic valve degeneration, moderate-severe prosthetic stenosis with one immobile valve leaflet and moderate pulmonary regurgitation.The physician discussed the eventual need to intervene on the valve but noted that they will continue to monitor the valve closely for now.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Event Description

At five (5) year follow-up clinical trial patient was reported to be nyha class i.Tte showed severe pulmonary stenosis (peak gradient 74 mmhg/mean gradient 44 mmhg) and at least moderate pulmonary regurgitation.Patient has received antiplatelet antithromboembolic therapy.The patient has no symptoms or limitations to activity.No indication or plan for intervention at study exit.

Event Description

It was learned a 15-year-old female clinical patient with a 21mm 11000a aortic valve implanted in the pulmonary position seven (7) years, one (1) month, underwent valve-in-valve procedure due to severe pulmonary stenosis/obstruction and moderate transvalvular pulmonary regurgitation and moderate total pulmonary regurgitation.Ecg showed probable left ventricular hypertrophy.Patient presented with nyha class iii symptoms.Tpvr was successfully performed with a 23mm s3 transcatheter valve.

• Brand Name: EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS
• Type of Device: TISSUE, 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 ; one edwards way; mle2; irvine, CA 92614 ; 9492506615
• MDR Report Key: 9638723
• MDR Text Key: 195111239
• Report Number: 2015691-2020-10292
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2017
• Device Model Number: 11000A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 25 KG