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

Model Number	7000TFX
Medical Device Problem Codes	Gradient Increase (1270); Perivalvular Leak (1457)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
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, the nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.Multiple requests for additional details regarding this event (i.E., medical records) have been performed; however, no additional information has been provided.The subject device is also unavailable for evaluation as it remains implanted in the patient.Therefore, the reported event could not be confirmed.There is currently insufficient information to determine the root cause of this event.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.If any additional information is received, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that a patient with a 25mm 7000tfx pericardial valve, implanted in the mitral position, underwent a valve-in-valve procedure after an implant duration of 12 years, three (3) months due to stenosis and paravalvular leak.The tmvr was performed successfully with a 26mm 9750tfx transcatheter valve.No additional information has been provided.
Event or Problem Description
It was reported that a patient with a 25mm edwards pericardial valve, implanted in the mitral position, underwent a valve-in-valve procedure after an unknown implant duration due to stenosis and paravalvular leak.The tmvr was performed successfully with a 26mm 9750tfx transcatheter valve.No additional information has been provided.
Additional Manufacturer Narrative
Additional manufacturer narrative: the device history record (dhr) could not be reviewed, as the device serial number was not provided.Updated h6 device code(s) by adding code-1457.Corrected h6 clinical code by replacing code-4581 with code-4580.Corrected h6 investigation conclusions by removing code-22.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12250451
• Report Number: 2015691-2021-04399
• Device Sequence Number: 20048711
• Product Code: DYE
• UDI-Device Identifier: 00690103167849
• UDI-Public: 00690103167849
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7000TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 08/23/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/13/2021; 09/09/2021
• 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
• Patient Age: 72 YR