MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problem Pulmonary Hypertension (4460)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

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.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 learned through medical records that the patient was taken to the operating room emergently post redo avr with a 23mm 11500a aortic valve on pod #1 due to dehiscence, causing paravalvular aortic insufficiency.Per medical records.It was noted that the patient had extremely friable tissues.Preoperative tee identified a new severe and torrential paravalvular aortic insufficiency.There was dehiscence of 1/3 of the newly replaced 23mm aortic valve between the right and noncoronary cusps.There was a large tear starting in the right coronary cusp of the valve and extending into the noncoronary cusp area.The paravalvular leak was repaired with six sutures with felts.The ascending aortic aneurysm was repaired with a 34mm hemashield graft.The patient was weaned from bypass.However, there was mild to at most moderated aortic insufficiency.Due to acidosis and progressive right and left ventricular dysfunction, the patient was placed on bypass again.Then, the patient was placed on central ecmo successfully.Protamine was administered and hemostasis was achieved.The patient was transferred to the icu in stable but critical condition.It was later learned that the patient expired on pod #2.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (health effect-impact code, type of investigation, investigation findings, investigation conclusions) valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Valve dehiscence is not a malfunction of the device.The root cause of this event was determined to be due to patient related factors, including 'extremely friable tissue'.The subject device is not available for evaluation as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• 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: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16154289
• MDR Text Key: 307258313
• Report Number: 2015691-2023-10131
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)260706(11)220707219462718
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

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: 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
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: 76 YR
• Patient Sex: Male