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 Codes	Dyspnea (1816); Fatigue (1849)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the device was not returned for evaluation due to potential risk of endocarditis.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 the implant patient registry and medical records, that a 27mm 3000 aortic valve was explanted after an implant duration of nine (9) years, four (4) months due to calcific degeneration and severe stenosis.The explanted valve was replaced with a non-edwards mechanical valve.Patient was taken to recovery post procedure.Per medical records, the patient presented with dyspnea on exertion and increase fatigue.Pre- op imaging demonstrate enlarging sinus of valsalva aneurysm with structural valve deterioration of the bioprosthetic aortic valve with severe as and reduced ef at 52%.The patient underwent a redo sternotomy in which the 27mm 3000 magna ease was explanted and replaced with non-edwards mechanical valve.Concomitantly, the patent underwent tricuspid valve repair using 32mm 6200 physio ring.Upon weaning from bypass, the patient was profoundly vasoplegic with minimal response to vasoconstrictors.Va ecmo circuit was placed without issue and the patient was transferred to cvicu in stable condition.The patient was discharged from hospital pod # 13.Per pathology report, fragments of fibroconnective tissue with dystrophic calcifications, necrosis, acute inflammation and associated necro inflammatory debris were observed.There were no definitive bacterial or fungal organisms identified in the tissue on routine staining.Pas f and gms did not identify fungal elements.Afb stain did not reveal acid-fast bacteria.There are no definitive vegetations identified; however, infectious endocarditis could not be completely ruled out on present specimen.The cut surfaces were focally calcified.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections g3, h6 (investigation findings, investigation conclusions).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 native bicuspid aortic valve (bav).Per the instructions for use (ifu), structural valve deterioration (svd) is a known potential risk associated with bioprosthetic heart valves.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency 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.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 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: 21756636
• Report Number: 2015691-2025-02529
• Device Sequence Number: 9749076
• Product Code: DYE
• UDI-Device Identifier: 00690103162271
• UDI-Public: (01)00690103162271(17)190615
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 06/15/2019
• Device Model Number: 3000
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2015
• 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; Life Threatening; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male