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

Model Number	6900P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
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 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.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.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The root cause of this event cannot be conclusively determined with the available information.However, the regurgitation in this case was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.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 notification that this patient with a 29mm 6900p mitral valve underwent a valve-in-valve procedure after an implant duration of 11 years and four (4) months due to severe intravalvular regurgitation.Structural deterioration of the valve or a perforation in the posteromedial aspect of the valve was suspected.There was no evidence of paravalvular dehiscence or leak.A 29mm sapien 3 transcatheter valve was implanted within the surgical edwards valve using the trans-septal approach.After the procedure, mitral valve was in good position with reasonable lv function.The patient was discharged to the critical care unit in stable condition.
Additional Manufacturer Narrative
H11: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
Additional information received: as per surgeon response, did not feel the valve failed prematurely.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11380741
• Report Number: 2015691-2021-01452
• Device Sequence Number: 19799784
• Product Code: DYE
• UDI-Device Identifier: 00690103152654
• UDI-Public: 00690103152654
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S01
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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 Model Number: 6900P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/05/2021
• 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: 75 YR