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

Model Number 11500A21

Device Problems Gradient Increase (1270); Patient-Device Incompatibility (2682); Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problems Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

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 aortic valve was been placed under consideration for valve-in-valve intervention after an implant duration of four (4) years, one (1) month due to unknown reasons.

Manufacturer Narrative

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.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was reported and later learned through medical records that a patient with a 21mm 11500a inspiris aortic valve underwent a valve in valve after an implant duration of four (4) years, three (3) months due to severe aortic stenosis, one non-functioning leaflet and ppm.A 23mm sapien was implanted with fracture of the bioprosthetic valve.The patient presented with chf, nyha class 3.Per medical records: the patient was referred to ct surgery for evaluation of aortic root enlargement and redo savr, given concern for ppm with initial savt< however, due to comorbidities including thrombocytopenia, along with previous stroke /tia, a decision was made to procedure with tavr viv with fracture of his surgical valve.An echo obtained post month post savr showed elevated gradient consistent with ppm.

Event Description

It was reported and later learned through medical records that a patient with a 21mm 11500a inspiris aortic valve underwent a valve in valve after an implant duration of four (4) years, three (3) months due to severe aortic stenosis caused by ppm.A 23mm sapien was implanted.The patient presented with fatigue.

Manufacturer Narrative

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.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 explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, the nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was reported that a patient with a 21mm 11500a inspiris aortic valve was been placed under consideration for valve-in-valve intervention after an implant duration of four (4) years, one (1) month due to severe aortic stenosis.The patient presented with fatigue.Per medical records, one (1) month post implantation of 21mm 11500a valve echo showed elevated mean gradient consistent with ppm.

• 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: 16369269
• MDR Text Key: 309461748
• Report Number: 2015691-2023-10783
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)200726
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2023

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
• Device Expiration Date: 07/26/2020
• Device Model Number: 11500A21
• Device Catalogue Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 02/16/2023; 03/21/2023; 03/22/2023
• Supplement Dates FDA Received: 03/09/2023; 03/21/2023; 03/24/2023
• Date Device Manufactured: 07/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male