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)

Patient Problem Dyspnea (1816)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Image evaluation: customer report of valve dehiscence could not be confirmed through image evaluation.One color picture of the inflow and one color picture of the outflow of the explanted valve were provided.The sewing ring was cut in multiple areas around the valve.Blue sutures were visible around the valve.One of the leaflets appeared to have two cuts on the outflow aspect.Echo summary: as per echo report, the submitted echocardiographic images are remarkable for: 1.Limited submitted images confined to a short axis view of the aortic valve and aortic root without and with superimposed cfd.2.An extensive, nearly circumferential (~ 270 degrees of 360 degrees) echo-lucent space around the aortic valve bioprosthesis consistent with partial valve dehiscence and a large paravalvular abscess with rupture.3.Probably torrential paravalvular aortic regurgitation (ar) involving what is presumably a ruptured paravalvular abscess.The submitted echocardiographic images support the reported findings of partial valve dehiscence (albeit without observed rocking motion of the bioprosthesis on the limited submitted images) with paravalvular abscess and probably torrential paravalvular ar.The findings are suggestive of prosthetic valve infective 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

Edwards received notification that this inspiris resilia valve model 11500a25 implanted in the aortic position was explanted after an implant duration of four (4) months due to severe aortic regurgitation caused by partial valve dehiscence.The subject device was implanted with three hemi-continuous sutures in prolene that broke and caused the dehiscence.The issue was observed on echo.An abscess under the left cusp was also observed.The valve was evaluated for endocarditis in the hospital laboratory and it was confirmed that there was no endocarditis.The patient presented with shortness of breath.Another inspiris resilia valve of the same size was implanted in replacement with 16 single sutures.Reportedly, during the redo procedure, a pericardial patch was sutured to repair the abscess damage.The patient was discharged.

Manufacturer Narrative

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.

Event Description

Edwards received notification that this inspiris resilia valve model 11500a25 implanted in the aortic position was explanted after an implant duration of four (4) months due to severe aortic paravalvular leak caused by partial valve dehiscence.He subject device was implanted with three hemi-continuous sutures in prolene that broke and caused the dehiscence.The issue was observed on echo.An abscess under the left cusp was also observed.The valve was evaluated for endocarditis in the hospital laboratory and it was confirmed that there was no endocarditis.The patient presented with shortness of breath.Another inspiris resilia valve of the same size was implanted in replacement with 16 single sutures.Reportedly, during the redo procedure, a pericardial patch was sutured to repair the abscess damage.The patient was discharged.

Manufacturer Narrative

Device dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of inadequate device 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 most likely cause is patient factors, including an abscess formation under the left cusp of the valve.

• 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; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16395427
• MDR Text Key: 309869276
• Report Number: 2015691-2023-10904
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/16/2023; 03/27/2023
• Supplement Dates FDA Received: 03/17/2023; 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Male