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

Model Number 11500A

Device Problem Insufficient Information (3190)

Patient Problems Pseudoaneurysm (2605); Insufficient Information (4580)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

H10: 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 from implant patient registry that a 27mm 11500a aortic valve was explanted and replaced with another 27mm 11500a inspiris resilia aortic valve after an implant duration of eight months and 25 days due to unknown reason.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

It was learned from implant patient registry and medical records that a 27mm 11500a aortic valve in aortic position was explanted after an implant duration of eight (8) months and twenty (25) days due to aortic arch endoleak type 1 causing prosthetic valve dysfunction.The valve was replaced with a 27mm 11500a aortic valve.The patient tolerated the procedure well with no complications and was transferred to icu in stable condition.The patient was discharged on pod# 5.Per medical records, a routine follow up cta showed a pseudoaneurysm of the distal anastomosis of the ascending aortic graft, the patient asymptomatic, the cta findings compatible with endoleak.The indication for surgery was type 1 endoleak and aortic valve dysfunction.The patient underwent pseudoaneurysm exclusion, a hemi-arch replacement with a 28mm gelweave graft that was anastomosed end to end to the aorta, following redo avr the ascending graft was beveled and sewn end to end to the stj (supra- coronary).It is noted the pseudoaneurysm was communicating with the aorta 1cm distal to the distal anastomosis towards the lesser curvature of the aortic arch.Post op tee showed no ar, low aortic gradients and normal lv.

Manufacturer Narrative

H11: corrective data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.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 LLC; 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: 18038395
• MDR Text Key: 326958780
• Report Number: 2015691-2023-17161
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2023
• 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: 59 YR
• Patient Sex: Male