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

Model Number 11500A23

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

H11: 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 via the patient registry that a patient with a 23mm 11500a inspiris valve underwent a redo aortic valve replacement procedure after an implant duration of three (3) months, 28 days due to unknown reasons.The explanted valve was replaced with a 21mm 11500a inspiris valve.

Manufacturer Narrative

A device history record (dhr) review was not performed, as no information regarding a device failure mode was provided.Furthermore, there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.An engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.An ifu review is unable to be performed, as no details regarding failure mode of the device were provided.A capa/scar/pra is not required as there are no confirmed product or labeling non-conformances and no other triggers are met.Based on the information available, a definitive root cause cannot be conclusively determined.

• 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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19055046
• MDR Text Key: 339552580
• Report Number: 2015691-2024-02638
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)270709(11)230710
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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 Model Number: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/14/2024
• Date Device Manufactured: 07/10/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male