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

Model Number 11500A

Device Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Insufficient Information (4580)

Event Date 02/10/2022

Event Type  Injury  

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

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.In this case, it was reported that this 11500a 19mm valve was explanted due to unknown reasons.Implant duration of the valve was approximately seven (7) days.The device was replaced with another 11500a valve, 23mm.No other details available at this time.

Event Description

It was reported via the implant patient registry that this 11500a 19mm valve was explanted due to patient prosthesis mismatch, resulting in bioprosthetic aortic stenosis.Implant duration of the valve was approximately seven (7) days.Per medical records, the initial avr intraoperative course was unremarkable and she was brought to the cvicu instable condition.Postoperatively, the patient was hypertensive and echo on pod #5 showed preserved left ventricular ejection fraction with moderate as.Therefore, the decision was made to re-operate and expand the aortic root to allow for a larger valve.The patient underwent redo-sternotomy aortic root enlargement, redo-avr with a 11500a 23mm valve.The patient was transported to the cticu in stable condition.Post-op echo showed aortic valve mean gradient of 11 with no stenosis or regurgitation and was discharged on pod #11 with stable vital signs.

Manufacturer Narrative

Updated sections a4, b5, b7 and h6 codes per additional information received on 05/19/2022.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.Ppm has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.The most likely cause of this event is procedural factors.

• 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: reginald santos ; 1 edwards way; mailtop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14178626
• MDR Text Key: 289976765
• Report Number: 2015691-2022-05326
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)220628(11)170629215592328
• 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
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: 11500A19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 83 KG