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

Model Number 8300AB19A

Device Problem Perivalvular Leak (1457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

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 19mm 8300ab valve in the aortic position, was explanted after an implant duration of 6 years, 11 months due to severe paravalvular regurgitation.The patient was asymptomatic.The explanted valve was replaced with a 21mm 11500a valve.The patient expired on pod#3 as a result of multisystem organ failure.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bio-prosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bio-prosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bio-prosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bio-prosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including chronic kidney disease, hyperlipidemia, chemotherapy, and diabetes mellitus.

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 19mm 8300ab valve in the aortic position, was explanted after an implant duration of six (6) years, eleven (11) months due to severe paravalvular regurgitation with an eccentrically directed jet.The patient was asymptomatic.The explanted valve was replaced with a 21mm 11500a valve.The patient expired on pod#3 as a result of multisystem organ failure.Per medical records, intraoperatively the aortic valve leaflets were found to be thickened and sclerosed.The valve was excised, and the area irrigated and suctioned out to get rid of any loose calcific particles.Concomitantly, the patient had ascending aorta replacement with a gelweave graft, and a re-do mvr ((b)(4)).Post operative tee revealed excellent valve function with no significant perivalvular leak.Patient tolerated well and was transferred to the icu in stable condition.

• 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: 18818389
• MDR Text Key: 336683003
• Report Number: 2015691-2024-01509
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 04/11/2024

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 Operator: Health Professional
• Device Expiration Date: 06/15/2018
• Device Model Number: 8300AB19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/01/2024; Not provided
• Supplement Dates FDA Received: 03/25/2024; 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female