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

Model Number	3000
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry and investigation that a patient with a 23mm 3000 aortic valve was explanted after an implant duration of 9 years, 9 months due to degeneration, heavy calcification, with severe stenosis and restricted opening.The explanted valve was replaced with a 23mm 11500a valve.Per medical records, the patient presented with chf chronic diastolic.The patient underwent redo - avr with a 23mm inspiris valve.Post bypass tee a well-seated prosthetic av with no pvl.The patient was transported in icu in critical but stable condition.The patient was discharged home with outpatient pt on pod#4.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
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
Updated sections: b6, g3, and g6.
Additional Manufacturer Narrative
Updated sections: g3, g6, h6 investigation findings, and investigation conclusions.A device history record (dhr) review 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 device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.Svd is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bhv 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.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient factors, including an implant duration of 7 or more years and hyperlipidemia (hld).
Additional Manufacturer Narrative
H3: customer reports of degeneration, heavy calcification, stenosis, and restricted opening were confirmed.X-ray demonstrated commissure 3 bent inward and heavy calcification on all three leaflets.Extrinsic calcific deposits were observed on the surfaces of all three leaflets.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1mm on leaflet 1 on the outflow aspect and 1mm on leaflet 3 on the inflow aspect.Host tissue on the stent circumference was minimal at both the inflow and outflow aspects.Calcification restricted leaflet mobility and led to stenosis.Sewing ring was partially cut around the valve and exposed the metal band near leaflet 1 on the inflow aspect.Wireform was exposed at commissures 2 and 3.Updated sections: d9, g3, g6, h2, h3, h6 type of investigation.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22038623
• Report Number: 2015691-2025-03908
• Device Sequence Number: 12792985
• Product Code: DYE
• UDI-Device Identifier: 00690103162257
• UDI-Public: (01)00690103162257(17)190405
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/21/2025

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: 04/05/2019
• Device Model Number: 3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 06/20/2025; 06/26/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/13/2025; 06/27/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2015
• 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: Male
• Patient Weight: 91 KG