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

Model Number	270025MM
Medical Device Problem Codes	Gradient Increase (1270); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	07/25/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient with a 25mm 2700 valve in the aortic position is under evaluation for valve-in-valve after an implant duration of 7 years, 6 months due to stenosis.Replacement valve information is unknown.
Additional Manufacturer Narrative
H10: 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.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated: b4, b5, b7, g3, g6, h2, h6.Corrected: h1, b2.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that a patient with a 25mm 2700 valve in the aortic position was under evaluation for valve explant after an implant duration of 7 years, 6 months due to severe stenosis.The patient presented with progressive exertional dyspnea.Per medical records, the patient was admitted with heart failure symptoms and was planned to undergo avr.The patient expired prior redo avr.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (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, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17561523
• Report Number: 2015691-2023-15287
• Device Sequence Number: 6854879
• Product Code: DYE
• UDI-Device Identifier: 00690103021615
• UDI-Public: (01)00690103021615(17)191116
• 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: 2016
• 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,Followup
• Report Date (Section B): 10/04/2023

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: 11/16/2019
• Device Model Number: 270025MM
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/25/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/22/2023; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2015
• 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: Death; Life Threatening; Other
• Patient Age: 62 YR
• Patient Sex: Female