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

Model Number	6900PTFX
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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 learned through implant patient registry that a patient with a 33mm 6900ptfx mitral valve, implanted in the tricuspid position, underwent a valve-in-valve procedure after an implant duration of 4 years, 4 months due to severe tricuspid stenosis.The procedure was performed with a 29mm 9755rsl valve.The patient was transferred to the cvpr for recovery.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: d4 (expiration date), g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions)."it was learned through implant patient registry that a patient with a 33mm 6900ptfx mitral valve, implanted in the tricuspid position, underwent a valve-in-valve procedure after an implant duration of 4 years, 4 months due to severe tricuspid stenosis." based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (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, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including hyperlipidemia (hld), end stage kidney disease (esrd) and implant position.

• 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: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17472399
• Report Number: 2015691-2023-15087
• Device Sequence Number: 12598021
• Product Code: DYE
• UDI-Device Identifier: 00690103163629
• UDI-Public: (01)00690103163629(17)220310
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S22
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 03/10/2022
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2018
• 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: 27 YR
• Patient Sex: Female