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

Model Number 11500A

Device Problems Degraded (1153); Gradient Increase (1270); Patient-Device Incompatibility (2682); Insufficient Information (3190); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 06/13/2023

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.

Event Description

Through implant patient registry it was learned that a 21mm 11500a aortic valve was explanted after an implant duration of 2 years, 1 months due to unknown reason.The explanted valve was replaced with a 23mm 11500a valve.

Event Description

Through implant patient registry it was learned that a 21mm 11500a aortic valve was explanted after an implant duration of 2 years, 1 months due to severe stenosis, degeneration, patient prosthetic mismatch and pannus.The patient presented with heart failure, nyha 111-1v, worsening sob and chest tightness.The explanted valve was replaced with a 23mm 11500a valve.Per medical records: the patient was readmitted approximately two weeks later with worsening sob, chf, tightness, blurry vision, a head ct confirmed a cerebral infarct in the posterior circulation, and in afib with rvr requiring successful cardioversion.The admission complicated preoperatively by cardiogenic shock and aki.The patients pre op indication was severe aortic stenosis, patient prosthetic mismatch and severe tr.A pre op tee showed ef low, with global hypokinesis, mild ms/mr, severe as and severe tr.The patient underwent avr with a 23mm 11500a valve, aortic root enlargement with patch and tricuspid valve repair with a 26mm non-edwards band.The post cpb showed a well seated aortic prosthetic valve with no leak and mild tr.The patient was transported to cicu in stable condition.It is noted the 21 mm 11500a aortic valve leaflets were moving freely but the underside of valve showed there was some element of pannus.Pathology of the explanted aortic valve showed valve cusps with extensive degeneration, no calcification or vegetations identified.Her post op course was complicated by hypoxic respiratory failure requiring several reintubations and hypoxic encephalopathy due to hypoxic ischemia.The patient was discharged on pod 18.

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.

Manufacturer Narrative

H10: additional manufacturer narrative: the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.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 may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including chronic kidney disease (ckd), hyperlipidemia (hld) and diabetes mellitus (dm).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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

• Brand Name: EDWARDS 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: 17419950
• MDR Text Key: 320038826
• Report Number: 2015691-2023-14904
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)240910(11)200911217334746
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Female