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

Model Number 11500A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Insufficient Information (4580)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.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

Through implant patient registry it was learned a 25mm 11500a aortic valve was explanted after two (2) months, two (2) days, due to unknown reasons.The patient had a ascending aorta aneurysm resection.The explanted device was replaced with a 23mm 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.

Manufacturer Narrative

The device was not retrieved as the patient had endocarditis.The cause of the event was most likely due to patient factors.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Through implant patient registry and medical records, it was learned a 25mm 11500a aortic valve was explanted after two (2) months, two (2) days, due to endocarditis and dehiscence.The patient had a ascending aorta aneurysm resection.The explanted device was replaced with a 23mm 11060a aortic valved conduit.Per medical records, 43-year-old male with polysubstance abuse disorder and recent history of aortic valve endocarditis s/p avr.Patient presented with severe chest pain and heart failure symptoms after using crack cocaine and was found to have valve dehiscence of his 25mm 11500a aortic valve with destruction of the aortic root from previous root abscess.Upon inspection of the 25mm 11500a aortic valve, complete destruction of the right and non coronary commissures were noted.Perforation of right coronary sinus with fistulous tract into right atrium.The 25mm 11500a aortic valve was separated from aorta at site of right/non coronary annulus with separation of annulus from native aorta.There was no gross evidence of purulence or active abscess, no evidence of vegetation on aortic valve.The 25mm 11500a aortic valve was explanted and replaced with a 23mm 11060a valved conduit with good hemostasis, coronary buttons reimplanted in normal anatomic position.Successful separation from cardiopulmonary bypass.Post chest closure, patient with sudden flash pulmonary edema which necessitated v-v ecmo; this was complicated by hypoxic arrest and conversation to v-a ecmo.The patient was transferred to icu with hemodynamics on ecmo support.

• 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: 18459704
• MDR Text Key: 332257121
• Report Number: 2015691-2024-00116
• Device Sequence Number: 1
• Product Code: LWR
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 01/11/2024
• 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: 43 YR
• Patient Sex: Male