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

Model Number	3000
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur 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.The subject device is not available for evaluation, as it remains implanted in the patient.The root cause for the stenosis remains indeterminable with the available information.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 patient with a 23mm 3000 aortic valve underwent a valve-in-valve procedure after an implant duration of nine (9) years, 10 months due to critical aortic stenosis.The patient presented with heart failure with preserved ef.A successful tavr was performed with a 23mm 9750tfx valve.The patient was discharged in stable condition to rehab facility on pod # 6.
Additional Manufacturer Narrative
H11: corrected data: corrected coding to section h6.

• Brand Name: REPLACEMENT HEART-VALVE
• Common Device Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA BIOPROSTHESES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11882331
• Report Number: 2015691-2021-03149
• Device Sequence Number: 19741233
• Product Code: DYE
• UDI-Device Identifier: 00690103162257
• UDI-Public: 00690103162257
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 02/12/2015
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention