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

Model Number	2800TFX
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cough (4457); Wheezing (4463)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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
Edwards received notification from pe retrospective study (china) that this 61-year-old patient with a 2800tfx23mm valve model implanted in aortic position underwent reintervention for a valve-in-valve procedure after an implant duration of eight (8) years and six (6) months due to structural deterioration which led to significant leaflet opening restriction, severe stenosis and mild regurgitation.Valve was performing with a mean gradient of 63mmhg and a velocity of 5.21m/s.These findings were detected on an ultrasound performed eighteen (18) days before the reintervention.As reported, patient presented mainly with cough and wheezing.A 24mm non-edwards transcatheter valve was implanted within the edwards surgical valve.Patient was discharged on postoperative day ten and was noted to be currently in a stable condition.
Additional Manufacturer Narrative
H11.Additional narrative/data: the device was not returned to edwards for further investigation, as the valve remained implanted due to a valve-in-valve replacement, and no images or medical records were provided.Structural valve deterioration (svd) is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bioprosthetic heart valve implantation.The common endpoint of all these factors is calcification and degradation.Svd is an acquired condition, intrinsic to bioprosthetic valves, characterized by deterioration of the leaflets or supporting structures, leading to thickening, calcification, tearing, or disruption of the prosthetic valve materials.These changes result in valvular dysfunction manifesting as stenosis and/or regurgitation with a consequent drop in hemodynamic efficacy of the valve.Despite the advancements in the heart valve industry, svd commonly begins 7- 8 years after implantation, with a considerably increased rate in patients with pertinent comorbidities and/or an implant duration of greater than 10 years.Prior investigations and extensive literature review have shown that svd is predominantly related to patient factors and implant duration rather than to manufacturing issues.Events related to device design, manufacturing, or use error tend to manifest at an earlier implant duration.Based on the information available, the most likely root cause is patient factors, including implant duration over 7 years.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20264859
• Report Number: 2015691-2024-07268
• Device Sequence Number: 8298677
• Product Code: DYE
• UDI-Device Identifier: 00690103177244
• UDI-Public: (01)00690103177244(17)190207
• 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: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 02/07/2019
• Device Model Number: 2800TFX
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2015
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 62 KG