MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC MODEL 11500A; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A27

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001); Device Stenosis (4066)

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

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported a patient with a 27mm 11500a aortic valve implanted in pulmonary position one (1) year, six (6) months, underwent valve-in-valve procedure due to severe pulmonary insufficiency.Tpvr was successfully performed with a 26mm 9750tfx transcatheter valve.

Manufacturer Narrative

Added information to b5, b7, h6.

Event Description

It was reported a patient with a 27mm 11500a aortic valve implanted in pulmonary position one (1) year, six months, underwent valve-in-valve procedure due to leaflet thrombosis/frozen leaflets with pulmonary stenosis, and severe pulmonary insufficiency.Tpvr was successfully performed with a 26mm 9750tfx valve.Tentative plan for plavix/eliquis as long term anticoagulant treatment.Per medical records, patient presented nyha ii symptoms with a history of noncompliance with eliquis.Pre-op ct showed the rightward and posterior leaflet stuck open with large coaptation gap, valve leaflet thickening concern for thrombus.Follow up echo showed worsening severe transvalvular regurgitation (mg of 17, peak gradient of 30).

Manufacturer Narrative

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.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.The cause was most likely due to patient factors.

• Brand Name: INSPIRIS RESILIA AORTIC MODEL 11500A
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17830533
• MDR Text Key: 324417156
• Report Number: 2015691-2023-16208
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)250908
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2023

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 Operator: Health Professional
• Device Model Number: 11500A27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 09/21/2023; 11/13/2023
• Supplement Dates FDA Received: 10/16/2023; 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 24 YR
• Patient Sex: Male