MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB21A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

H10: 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.

Event Description

Through implant patient registry it was learned that a 21mm 8300ab valve in the aortic position was explanted after an implant duration of 4 years, 9 months due to unknown reason.The explanted valve was replaced with a 21mm 11500a valve.

Manufacturer Narrative

H11: additional manufacturer narrative: updated: b4, d9, g3, g6, h2, h3, h6 h3: evaluation summary: complaint was of unknown reasons was unable to be confirmed.X-ray demonstrated frame was expanded, deformed and pushed inward around all three commissures.Host tissue was heavy at the frame inflow aspect and minimal at the outflow aspect.As received, all three leaflets had cuts of approximately 10mm x 12mm on leaflet 1, 3mm on leaflet 2, and 12mm x 14mm on leaflet 3.The cuts had a smooth and straight edge; cut leaflet were not returned.Mechanical damage marks were also observed on the outflow aspect of leaflet 2.Damages appeared serrated and did not penetrate leaflets.Sewing ring was cut around the valve and exposed the wireform and metal band on the outflow aspect.Cut off sewing ring fragment was not returned with valve.Wireform was also exposed around commissures 1 and 3.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

Through implant patient registry it was learned that a 21mm 8300ab valve in the aortic position was explanted after an implant duration of 4 years, 9 months due to unknown reason.The explanted valve was replaced with a 21mm 11500a valve.Per product evaluation, host tissue was heavy at the frame inflow aspect and minimal at the outflow aspect.Mechanical damage marks were also observed on the outflow aspect of leaflet 2.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• 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: 18965756
• MDR Text Key: 338431681
• Report Number: 2015691-2024-02261
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487(17)210907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• 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: 79 YR
• Patient Sex: Female