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

Model Number 11500A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and 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

Through implant patient registry it was learned a 25mm 11500a aortic valve was explanted after an implant duration of four (4) years, due to unknown reasons.The explanted device was replaced with a 25mm 11060a aortic valved conduit.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.

Event Description

Through implant patient registry and medical records, it was learned a 25mm 11500a aortic valve was explanted after an implant duration of four (4) years, due to type a aortic dissection and ascending aortic aneurysm.The explanted device was replaced with a 25mm 11060a aortic valved conduit.Per medical records, the patient presented with chest pain dizziness.Workup revealed class iii nyha heart failure, ascending aortic aneurysm, and type a aortic dissection extending to the aortic root.The patient was transported to another hospital for further care.Upon admission, the right lower extremity puls was absent requiring femoral artery bypass surgery.The vascular procedure was complicated with compartment syndrome necessitating lower extremity fasciotomy.While stil intubated, the patient was taken same day to the or and underwent total replacement of the root with a 25rmm 11060a aortic valved conduit and entire ascending aorta hemi-arch with a 30mm graft along with cabg x1 to replace the left main ca.The patient entered a profound metabolic situation and required aggressive resuscitation with vasopressor support.He was placed on venoarterial ecmo due to difficulty weaning from cpb machine.The patient remained coagulopathic and chest bleeding continued.Due to poor condition, the decision was made to place the patient on dnr.Life support has been stopped and the patient expired on pod# 1.

Manufacturer Narrative

Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being 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 ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18990534
• MDR Text Key: 338883939
• Report Number: 2015691-2024-02394
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)240827
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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): Death; Required Intervention; Life Threatening; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male