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

Model Number	6900PTFX
Medical Device Problem Codes	Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Of note, this pericardial mitral valve was initially used off-label as it was implanted in the tricuspid position.Per the instructions for use (ifu), the perimount theon mitral pericardial bioprosthesis model 6900ptfx is designed for the mitral position.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 29mm 6900ptfx mitral valve, implanted in the tricuspid position, underwent a valve-in-valve after an implant duration of four years, five months due to stenosis.The ttvr was performed with a 29mm 9600tfx valve.
Event or Problem Description
It was reported that a patient with a 29mm 6900ptfx mitral valve, implanted in the tricuspid position, underwent a valve-in-valve after an implant duration of four years, five months due to severe tricuspid stenosis, severe regurgitation, and thickened leaflets.The ttvr was performed with a 29mm 9600tfx valve.The patient was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections b5, b6, h6 (device code, type of investigation).
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: d4 (expiration date), h4 (device manufacturer date), and h6 (type of investigation, investigation findings, and investigation conclusions).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.The root cause of this event was most likely due to patient related factors and the progression of the underlying valvular disease pathology contributed to the event.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON 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; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 12862325
• Report Number: 2015691-2021-06467
• Device Sequence Number: 11914369
• Product Code: DYE
• UDI-Device Identifier: 00690103163605
• UDI-Public: (01)00690103163605(17)200608
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S22
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2020
• Device Model Number: 6900PTFX
• 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: 11/02/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 01/05/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/14/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male