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

Model Number	2800
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gradient Increase (1270)
Health Effect - Clinical Codes	Pleural Effusion (2010); Insufficient Information (4580)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stenosis and/or regurgitation, 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 and/or regurgitation.The subject device is not available for evaluation.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis and regurgitation in this case were most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.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 learned that the patient had a 27mm 2800 pericardial valve, implanted in the pulmonic position, underwent an attempt for a valve-in-valve procedure after an implant duration of 16 years, one (1) month due to stenosis and insufficiency.The patient underwent balloon valvuloplasty of the bioprosthetic valve with intentional fracture of the valve ring to deliver a sapien valve.The procedure was not successful due to the prolong procedure time and the fluoroscopy time.The procedure had to be staged.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Updated d4 expiration date updated d4 unique identifier (udi) number updated h4 device manufacturer date updated h6 type of investigation by adding code-3331 h11: corrected data: corrected h6 impact code by replacing code-4607 with code-4629 corrected h6 clinical code by replacing code-4580 with code-2021.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12411692
• Report Number: 2015691-2021-04967
• Device Sequence Number: 17044536
• Product Code: DYE
• UDI-Device Identifier: 00690103021684
• UDI-Public: 00690103021684
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 11/01/2021

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: 06/30/2005
• Device Model Number: 2800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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: 29 YR