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

Model Number	7300TFX
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the device was not returned for evaluation, as it remains implanted.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.Refer to mfr report number 2015691-2025- 08665 for valve-in-valve (tavr) procedure information involving this patient.
Event or Problem Description
It was reported and learned through investigation that a patient with a 27mm 7300tfx mitral valve underwent a valve-in-valve procedure after an implant duration of 4 years, 9 months due to restricted leaflet motion with moderate stenosis and regurgitation.The patient presented with shortness of breath and palpitations.The tmvr was successfully performed with a 29mm 9755rsl valve in a open procedure.The patient was transferred to ct-icu in stable condition.Per medical records, pre-op echo showed abnormal bioprosthetic mitral valve with moderately increased gradients (vmax 2.7 m/s, mean gradient 7mmhg.Pre-op tee showed mitral valve with restricted leaflet motion resulting in a mg 6 mmhg; there is also moderate, central regurgitation of the prosthetic valve.Concomitantly, a 21mm 3300tfx aortic valve underwent a valve-in-valve procedure, and tvr repair for severe native tr with a 28mm 6200 rings.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, b5, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions).Leaflet immobility or restricted motion has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Leaflet immobility or restricted motion occurring post-procedurally is typically related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing deficiency.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.The most likely root cause is patient factors, including chronic kidney disease.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.
Event or Problem Description
It was reported and learned through investigation that a patient with a 27mm 7300tfx mitral valve underwent a valve-in-valve procedure after an implant duration of 4 years, 9 months due to restricted leaflet motion with moderate-severe symptomatic stenosis.The patient presented with shortness of breath and palpitations.The tmvr was successfully performed with a 29mm 9755rsl valve in a open procedure.The patient was transferred to ct-icu in stable condition.Per medical records, pre-op echo showed abnormal bioprosthetic mitral valve with moderately increased gradients (vmax 2.7 m/s, mean gradient 7mmhg.Pre-op tee showed mitral valve with restricted leaflet motion resulting in a mg 6 mmhg; there is also moderate, central regurgitation of the prosthetic valve.Intraoperatively, the prosthetic mitral leaflets were severely restricted and completely removed.A true balloon was used to fracture the valve frame.A 29mm s3 was deployed without issue.Concomitantly, a 21mm 3300tfx aortic valve underwent a valve-in-valve procedure, and tvr repair for severe native tr with a 28mm 6200 ring.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE 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: 23342608
• Report Number: 2015691-2025-08667
• Device Sequence Number: 15396246
• Product Code: DYE
• UDI-Device Identifier: 00690103186260
• UDI-Public: (01)00690103186260(17)220417(11)180418
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2025

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: 04/17/2022
• Device Model Number: 7300TFX
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2018
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 72 KG