MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 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 Insufficient Information (4580)

Event Date 03/22/2022

Event Type  Injury  

Manufacturer Narrative

The patient died while using a medical product, but there was no suspected association between the death and the use of the product.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

Through medical records, it was learned that 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 vasoplegio 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 an unsurvivable situation due to brain hypoperfusion and the patient expired.

Manufacturer Narrative

H11: corrected data: mfr #2015691-2022 -05071 is a duplicate report and was already submitted under mfr #2015691-2022-04555.

• Brand Name: 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14108488
• MDR Text Key: 289286579
• Report Number: 2015691-2022-05071
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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: 03/22/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 04/20/2022
• 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; Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male