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

Model Number 8300AB

Device Problems Gradient Increase (1270); Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Myocardial Infarction (1969); Insufficient Information (4580)

Event Date 08/07/2023

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.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 through implant patient registry that a 19mm 8300ab aortic valve was explanted after an implant duration of four years, nine months due to unknown reason.The replacement valve is a 21mm 11500a resilia aortic valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.

Event Description

It was learned through implant patient registry and medical records that a 19mm 8300ab aortic valve in aortic position was explanted after an implant duration of four(4) years, nine (9)months and 14 days due to small undersized valve with severe aortic stenosis.The patient presented with nstemi.The replacement valve is a 21mm 11500a aortic valve.The patient was discharged on pod# 7.The patient underwent redo sternotomy and redo avr.The patient underwent concomitant mvr with a 25mm mitris valve.The echo showed the valves working well with no pvl.The patient tolerated the procedure well and transferred to icu.

Manufacturer Narrative

H10: additional 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.Engineering evaluation summary: per drm (b)(4), rev d, patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17726348
• MDR Text Key: 323149712
• Report Number: 2015691-2023-15859
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194470
• UDI-Public: (01)00690103194470(17)211114
• 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: 10/26/2023

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 Expiration Date: 11/14/2021
• Device Model Number: 8300AB
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female