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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

The subject device is not requested due to endocarditis.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 reported that a patient with a 23mm 11500a aortic valve implanted for 47 days underwent redo avr with aortic root replacement with a 11060a due to endocarditis.The patient expired.The infection caused abscess to form which required a root replacement the patient had trouble coming off pump with rv failure, was vasoplegic, and ultimately expired.The physician reinterred this was no issue with the inspiris or konect, the patient was just very sick.

Manufacturer Narrative

H11 corrected data: sections b5, b7, h6 health effect - clinical code, device code(s), and type of investigation.

Event Description

It was reported via the implant patient registry that an 25mm 11500a aortic valve, implanted for 47 days underwent redo avr with aortic root replacement with a 11060a aortic valved conduit due to dehiscence and severe perivalvular ar.Per the medical records, the patient presented with covid pneumoniaand acute hypoxic respiratory failure, c/b cardiac arrest, septic shock, acute renal failure on hd, and recurrent abscess formation, multiple foci of infection including left hip, gluteus and l-spine.S/p redo avr and patch closure of vsd (b)(6) 2022.The valve was inspected, and it had multiple vegetations on it.The valve was removed and debrided.The valve was replaced with a 23mm 11500a valve.Post bypass echo demonstrated a restrictive septal defect which is likely residual as well as 2 trace paravalular leaks.Given the setting, this seems acceptable and the patient was decannulated.The surgeon had to go back on for a few more minutes to repair a leak in the aortotomy suture line and separated from bypass again.Another echo came in and more concerned about a pvl leak than previously around the av.This could suggest dehiscence of the portion of the valve.Given the patient's life-threatening coagulopathy, there is nothing to be done about that at the time of procedure.The patient was transferred to the icu resuscitated him correct his coagulopathy.An echo on pod # 20 23mm lnspiris resilia bioprosthetic valve in the aortic position with concern for partial dehiscence and severe paravalvular aortic regurgitation.Limited evaluation due to acoustic shadowing therefore cannot exclude avr vegetation, rv severely reduced , vsd with bidirectional shunting, severe tr.A transcatheter approach to close the paravalvular leak and perform vsd closure was initially discussed but decided to hold off to sort out his leukocytosis and allow his volume status to improve.On pod #47, the patient was taken back to the or due to severe pvl leaks around the aortic valve.The valve was inspected and there were several areas of dehiscence.The valve was removed and replaced with a 25mm konnect valved conduit.Post bypass echo showed well seated and well-functioning prosthesis with acceptable gradients; however, the patient was profoundly vasoplegic and hypotensive.Shortly after separating from cpb, the rv ballooned out and failed and requiring re-institution of bypass.After 30 minutes of rest, the patient separated from cbp, but the rv again eventually dilated.The patient was placed on central ecmo.Even with full flow, the patient profound vasoplegia requiring maximal vasoactive support but with little effect.It was clear that this was not survivable situation due to brain hypoperfusion and the patient expired.

Manufacturer Narrative

Updated sections: d4 expiration date, h4, h6 component codes, type of investigation, investigation findings, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.Through further investigation, it was determined that the root cause of this event occurred due to procedural factors.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: reginald santos ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13847678
• MDR Text Key: 287615793
• Report Number: 2015691-2022-04555
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)250421(11)210422217742645
• 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: 05/05/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/22/2022
• Supplement Dates Manufacturer Received: 04/20/2022; 05/04/2022
• Supplement Dates FDA Received: 04/22/2022; 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male