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

Model Number	2800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Dyspnea (1816); Dizziness (2194); Insufficient Information (4580)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: 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 27mm 2800 aortic valve was explanted after an implant duration of 4 years,11 months due to leaflet perforation and stenosis.The explanted valve was replaced with a 25mm 11500a inspiris relisa aortic valve.Per pathology, explanted aortic valve consisted of one leaflet with 4 holes.Gross exam diagnosis: leaflet perforation.This is a 64-year-old male patient.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.
Event or Problem Description
It was learned through implant patient registry that a patient with a 27mm 2800 aortic valve was explanted after an implant duration of 4 years,11 months due to leaflet perforation with severe regurgitation.Patient presented with shortness of breath and dizziness.The explanted valve was replaced with a 25mm 11500a inspiris relisa aortic valve.Per medical records, patient presented with severe aortic regurgitation.Intraoperatively, four large perforations on right leaflet noted.Surgeon speculated that the perforations were likely due to adjacent corknots that had sharp edges pointing toward leaflets hitting the leaflet in systole.The valve was removed and replaced with a 25mm 11500a aortic valve.Post-procedure tee demonstrated well-seated aortic valve with normal gradients.Per pathology, explanted aortic valve consisted of one leaflet with 4 holes.Gross exam diagnosis: leaflet perforation.This is a 64-year-old male patient.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: updated sections : b7, g3, g6, h2,h6 ( type of investigation) corrected sections: b5, h6 (component code, clinical code, device code, investigation findings and investigation conclusions).If the surgeon does not cut sutures close to the knot, excess suture tails may result in abrasion, perforation, or damage to the leaflet.This may require an exchange of the device.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.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 procedural factors, including surgeon speculated that the perforations were likely due to adjacent corknots that had sharp edges pointing toward leaflets hitting the leaflet in systole.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.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22198482
• Report Number: 2015691-2025-04806
• Device Sequence Number: 9311660
• Product Code: DYE
• UDI-Device Identifier: 00690103021677
• UDI-Public: (01)00690103021677(17)220115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 01/15/2022
• Device Model Number: 2800
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male