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

Model Number 11500AJ25

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  Injury  

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

Edwards received information through its implant patient registry that a 25mm 11500aj aortic valve was explanted for bentall surgery due to ascending aorta dilation after a duration of approximately one (1) year and two (2) months.A smaller size same model 23mm 11500aj aortic valve was implanted in replacement.The device was not returned for evaluation as it was discarded at the hospital.There was no allegation of device malfunction.

Manufacturer Narrative

On occasion valves or rings may be explanted with no evidence of malfunction and are otherwise performing as intended.(.E.G.Graft replacement/repair, or open-heart surgery for an unrelated reason).If an indwelling ring or valve has been present for many years, the surgeon may elect to replace it during an unrelated cardiac surgery.The explanted device is not available for evaluation as it was discarded at the hospital.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.Based on the available information, progression of the patients underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction likely contributed to this event.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.

• 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; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13101387
• MDR Text Key: 283234682
• Report Number: 2015691-2021-07096
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103198898
• UDI-Public: (01)00690103198898(17)211106
• 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,Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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 Expiration Date: 11/06/2021
• Device Model Number: 11500AJ25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 01/31/2022
• Date Device Manufactured: 11/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female