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

Model Number	270023MM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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 2700 pericardial aortic valve underwent a valve-in-valve procedure after an implant duration of five (5) years, 11 months due to aortic regurgitation.The tavr procedure was performed with a 23mm 9750tfx transcatheter valve.The patient tolerated the procedure well and left the or in stable condition.Per the physician, the valve did not fail but instead succumbed to the disease process.
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) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13155352
• Report Number: 2015691-2022-03211
• Device Sequence Number: 17180496
• Product Code: DYE
• UDI-Device Identifier: 00690103021608
• UDI-Public: (01)00690103021608(17)190621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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
• Device Expiration Date: 06/21/2019
• Device Model Number: 270023MM
• Device Catalogue Number: 270023MM
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/11/2022
• Date Device Manufactured: 06/22/2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male