MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A21

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

Event Type  Injury  

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.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 Description

It was reported that a patient with a 21mm 11500a inspiris valve was placed under evaluation for valve-in-valve intervention after an implant duration of 11 months due to aortic stenosis.

Manufacturer Narrative

H11: additional manufacturer narrative: updated: b4, d4, g3, g6, h2, h4, h6 the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.No relevant non-conformances were identified.The subject device was not returned for evaluation as it remains implanted within the patient and no pictures or medical records were provided for evaluation.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards' valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.Bioprosthetic valve regurgitation and/or stenosis can be attributed to structural valve deterioration and/or nonstructural valve dysfunction (nsvd).Nsvd is any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nonstructural dysfunction refers to problems that do not directly involve valve components yet results in dysfunction of the prosthetic valve; such problems can include entrapment by pannus, tissue, or suture, malposition, thrombosis, technical errors, or patient prosthesis mismatch.Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Based on the information available, a definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.An edwards defect has not been confirmed.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19005637
• MDR Text Key: 338943520
• Report Number: 2015691-2024-02455
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)261019(11)221020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male