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

Model Number	3000TFX
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.If additional information is received a supplemental mdr will be submitted.The device history record 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.Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Replacement of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis or non-calcific degeneration and/or endocarditis.The cause of the event cannot be determined.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
Edwards received information a patient with a 27mm aortic valve implanted for an unknown implant duration underwent valve-in-valve procedure due to unknown reasons.A 23mm transcatheter valve was implanted inside the 27mm valve.
Additional Manufacturer Narrative
Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.Structural valve deterioration (svd) is the most common reason for bioprostheses 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.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.The cause of the event cannot be determined; however, patient factors and progression of underlying valvular disease likely impacted the event.
Event or Problem Description
Edwards received information a patient with a 27mm aortic valve implanted 11 years, eight (8) months, underwent valve-in-valve procedure due to severe prosthetic aortic regurgitation with no paravalvular leak.Patient presented with rapid onset of dyspnea and orthopnea.A 26mm 9750tfx was implanted inside the 27mm valve.The patient tolerated the procedure well and was transferred to the csu in stable condition.Per physician, surgical valve prematurely failed.
Additional Manufacturer Narrative
The device history record 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.The cause of the event was due to patient factors and progression of underlying valvular disease.

• 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: gail warner ; 1 edwards way; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12606790
• Report Number: 2015691-2021-05611
• Device Sequence Number: 1337033
• Product Code: DYE
• UDI-Device Identifier: 00690103163674
• UDI-Public: (01)00690103163674(17)230224
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 11/18/2021

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: 08/12/2011
• 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: 09/16/2021
• Supplement Date Received by Manufacturer: 10/18/2021; 11/16/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/12/2021; 11/18/2021
• Date Device Manufactured: 08/12/2009
• 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: 65 YR
• Patient Sex: Male