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

Model Number	6900P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via the implant patient registry that a 27mm (b)(4) bioprosthetic mitral valve, implanted for 12 years and seven (7) months, was explanted due to unknown reasons.The explanted device was replaced with a 29mm (b)(4) bioprosthetic valve.The implantation data card indicated that the device explant was due to deficiency of the original device.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The root cause of this event cannot be determined with the available information.However, this event 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 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 PLUS 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: 13101070
• Report Number: 2015691-2021-07095
• Device Sequence Number: 14375988
• Product Code: DYE
• UDI-Device Identifier: 00690103152647
• UDI-Public: 00690103152647
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 01/17/2013
• Device Model Number: 6900P
• Device Catalogue Number: 6900P27MM
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 02/04/2022
• Date Device Manufactured: 01/18/2009
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female