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

Model Number	6900PTFX
Medical Device Problem Codes	Calcified (1077); Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available for evaluation, as it remains implanted in the patient.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 this patient with a 6900ptfx 31mm mitral valve, implanted for five (5) years and seven (7) months, is being evaluated for a valve-in-valve procedure due to unknown reasons.
Additional Manufacturer Narrative
Updated sections: b5, b6, b7, h6 component code, health effect - impact code, device code(s), and type of investigation.
Event or Problem Description
It was reported that this patient with a 6900ptfx 31mm mitral valve, implanted for five (5) years and seven (7) months, was evaluated for a valve-in-valve due to severe stenosis with moderate-severe regurgitation secondary to thickened leaflets and possible leaflet thrombosis with minimal calcification.He is not candidate, due to concern that the tavr will likely cause left ventricular outflow tract obstruction.The patient is recommended for redo mitral valve replacement with a mechanical valve.Per medical records echo (6/14/2022) showed: bioprosthetic mitral valve with laminar 3 leaflet low-attenuation, thickening predominantly along the basilar to mid leaflets with only a small focus of calcification seen along the inferior leaflet free margin.Given only minimal calcification, these findings could reflect the sequela of leaflet thrombosis.No pedunculated or mobile leaflet vegetation or thrombus is seen.There is 4 mm x 3 mm tiny thrombus adherent to the inferior left lateral wall of the left atrium just above the mitral annulus.
Additional Manufacturer Narrative
Updated sections: b5, d4 expiration date, h4, h6 device code(s), type of investigation, investigation findings, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.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.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.
Event or Problem Description
It was reported that this patient with a 6900ptfx 31mm mitral valve, implanted for five (5) years and seven (7) months, was evaluated for a valve-in-valve due to severe stenosis with moderate-severe regurgitation secondary to thickened leaflets and possible leaflet thrombosis with minimal calcification.He is not candidate, due to concern that the tavr will likely cause left ventricular outflow tract obstruction.The patient is recommended for redo mitral valve replacement with a mechanical valve.Per medical records echo (b)(6) 2022 showed: bioprosthetic mitral valve with laminar 3 leaflet low-attenuation, thickening predominantly along the basilar to mid leaflets with only a small focus of calcification seen along the inferior leaflet free margin.Given only minimal calcification, these findings could reflect the sequela of leaflet thrombosis.No pedunculated or mobile leaflet vegetation or thrombus is seen.There is 4 mm x 3 mm tiny thrombus adherent to the inferior left lateral wall of the left atrium just above the mitral annulus.Per follow up with the surgeons office, thrombosis was not confirmed, surgery is schedule in 1 week.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14895591
• Report Number: 2015691-2022-06607
• Device Sequence Number: 12021959
• Product Code: DYE
• UDI-Device Identifier: 00690103163612
• UDI-Public: (01)00690103163612(17)190628
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022

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: 06/28/2019
• Device Model Number: 6900PTFX
• Device Catalogue Number: 6900PTFX31
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 07/08/2022; 08/04/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/02/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male