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); Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

Additional narratives: surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.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

It was reported that a 23mm aortic valve developed regurgitation and prosthesis patient mismatch after an approximate implant duration of 3 months.The patient currently is asymptomatic and is being evaluated for a valve-in-valve procedure.Per index procedure records, after implantation of the 23mm inspiris valve, post bypass echo showed lv function with a normally functioning aortic valve with no evidence of any paravalvular leak.On 3-month post-op visit the tte showed increased gradient due to prosthesis patient mismatch.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b4, b6, g3, g6, h2.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b4, d4, g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions).Complaint is confirmed through provided medical records.There is no evidence to suggest an edwards manufacturing defect.Capa/scar is not required.Root cause analysis: per imaging evaluation, the submitted echocardiographic images are remarkable for.Documentation of high transvalvular velocity and gradients on both sets of tte images, and documentation of normal bioprosthesis leaflet appearance and motion on the latter tte and no suggestion of anatomic structural valve deterioration or ar on either.Both submitted tte studies document high transvalvular velocity and gradients in the absence of bioprosthesis dysfunction.There is a small interval increase in velocity and gradients between the (b)(6) 2022 tte and the (b)(6) 2022 tte accompanied by an associated increase in svi; suggesting that incrementally higher flow probably accounts for the observed small changes in hemodynamics.Additional factors that could be contributing to high velocity and gradients in the absence of prosthesis dysfunction include intracavitary lv systolic flow acceleration and pressure recovery.A dhr review was performed and no related manufacturing nonconformances were identified.Per drm (b)(4), rev d, 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.Evaluation of provided tee images was able to confirm the customer report of elevated gradients but was unable to confirm the report of aortic regurgitation.Based on the information provided, a definitive root cause was unable to be determined.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17100989
• MDR Text Key: 316943428
• Report Number: 2015691-2023-13564
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)260223(11)220224219222680
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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; Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male