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

Model Number	2800
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a 23mm 2800 aortic valve in pulmonary position was disabled via valve in valve procedure after an implant duration of seven (7) years, 4 months due to unknown reason.Tpvr was completed with a 23mm 9600tfx transcatheter valve.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
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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, g3, g6, h2, h6 (investigation findings, and investigation conclusions).A device history record (dhr) review was not performed, as no information regarding a device failure mode was provided.Furthermore, there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error (doc-0101337, rev p).Engineering evaluation summary: 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.Per doc-0101337, rev p, an engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.An ifu review is unable to be performed, as no details regarding failure mode of the device were provided.Per doc-0101337, rev p, and doc-0076862, rev o, a capa/scar/pra is not required as there is no confirmed product or labeling non-conformances and no other triggers are met.Based on the information available, a definitive root cause cannot be conclusively determined.All pertinent information available to edwards lifesciences has been submitted.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: h6 (component code, clinical code, device code and type of investigation).
Event or Problem Description
It was learned through implant patient registry and investigation that a 23mm 2800 aortic valve in pulmonary position was disabled via valve-in-valve procedure after an implant duration of seven (7) years, 4 months due to regurgitation with progressive increase in gradients (peak 40-50mmhg).The patient presented with shortness of breath.Tpvr was completed with a 23mm 9600tfx transcatheter valve and patient was stable at the end of the procedure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, g3, g6, h2, 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.Engineering evaluation summary: per technical summary 33069, rev a, regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.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.Per technical summary 31081, rev a, 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.Per (b)(4), devices implanted 5 years or greater with calcification, dehiscence, leaflet tears, thickened leaflet, pannus, or structural valve deterioration (stenosis, regurgitation) reported as the complaint do not require an engineering evaluation.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.Per (b)(4), a capa/scar/pra is not required, as there are no confirmed product or labeling non-conformances, and no other triggers are met.The most likely cause is patient factors, including implant position, patient's age at time of implant and history of congenital heart disease.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19508757
• Report Number: 2015691-2024-04467
• Device Sequence Number: 7498419
• Product Code: DYE
• UDI-Device Identifier: 00690103021660
• UDI-Public: (01)00690103021660(17)200511
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2024

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: 05/11/2020
• Device Model Number: 2800
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 07/18/2024; 08/19/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/17/2024; 08/12/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2016
• 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; Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male