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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 07/29/2021

Event Type  Injury  

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 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.The subject device is not available for evaluation, as it remains implanted in the patient.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 25mm 11500a aortic valve implanted in pulmonary position for 1 year and 8 months underwent a valve-in-valve procedure due to stenosis and regurgitation.The procedure was performed with a 29mm 9600tfx transcatheter valve.

Manufacturer Narrative

Updated sections: b5, b6, b7, d4 expiration date and udi, h4 and h6 health effect - clinical code and type of investigation.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

Event Description

It was reported that a patient with a 25mm 11500a aortic valve implanted in pulmonary position for 1 year and 8 months underwent a valve-in-valve procedure due to moderate stenosis and mild to moderate insufficiency and associated severe rv dilation.The patient is sob with mild exertion.The procedure was performed with a 29mm 9600tfx transcatheter valve.

Manufacturer Narrative

Updated section: h6 investigation findings and investigation conclusions.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.

Manufacturer Narrative

Journal article: transcatheter pulmonary valve-in-valve implantation within the expandable inspiris resilia bioprosthetic valve by bativala et al., 2022, received on 01/20/2022.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.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 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.

Event Description

It was reported that a patient with a 25mm 11500a aortic valve implanted in pulmonary position for 1 year and 8 months underwent a valve-in-valve procedure due to leaflets frozen in a nearly open position, with moderate stenosis and mild to moderate insufficiency and associated severe rv dilation.The patient is sob with mild exertion.The procedure was performed with a 29mm 9600tfx transcatheter valve.Additional information received through review of journal article related to this case: intracardiac echocardiography (ice) was performed initially and demonstrated that two of the bpv leaflets were frozen in a nearly open position, resulting in the mixed dysfunction.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12465431
• MDR Text Key: 271304670
• Report Number: 2015691-2021-04822
• Device Sequence Number: 1
• Product Code: LWR
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 11500A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female