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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Patient Device Interaction Problem (4001)

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

Event Date 01/12/2024

Event Type  Injury  

Event Description

Edwards received notification that a 8300ab23 valve was explanted after five (5) months and fourteen (14) days due to severe paravalvular leak and inclusion of the prosthesis on the anterior leaflet causing mitral insufficiency detected during a routine follow up echo.The valve was implanted by full sternotomy concomitantly with three (3) cabg.As reported, first t was sutured the distal connections of the bypass (3 vessels), then the valve was implanted and finally it was connected the proximal end of the vessels to complete the bypass.After aortic valve implant procedure, there was no mitral insufficiency and aortic gradients and prosthetic area were correct.There were no sizing nor balloon inflation problems.No cardiac shunts or images suggestive of thrombi were evident.The patient was asymptomatic.As per information provided, the valve may be dysfunctional due to eccentric hypertrophy of the left ventricle leading to prosthesis malposition and increased left ventricular filling pressures.During the redo surgery, no mitral insufficiency was observed and the aortic valve was correctly positioned and all three sutures were placed properly.However, pericardium liquid with bacterial infection was confirmed by microbiological analysis and caused retraction of the tissue was found.There were no signs of infection.Valve was not analyzed for endocarditis.A 21mm inspiris valve was implanted in replacement.The mitral valve did not present insufficiency, this was confirmed by tee during surgery.No repair or replacement of the mitral valve was necessary.The patient presented renal complications and passed away.

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.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic 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 bioprosthesis 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 bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic 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.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.The heart is a multivalvular system.Repair or replacement of one valve may affect the function of the adjacent valve by changing the heart structure and hemodynamics.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The most likely cause for the reported event of device interferes with patient anatomy is patient factors, including eccentric hypertrophy of the left ventricle leading to prosthesis malposition and increased left ventricular filling pressures.

Manufacturer Narrative

Added information to section h8 (usage of device).Updated section b5 (describe event or problem).

Event Description

Edwards received notification that a 8300ab23 valve was explanted after five (5) months and fourteen (14) days due to severe paravalvular leak.Also, the valve appeared to be dysfunctional due to eccentric hypertrophy of the left ventricle leading to prosthesis malposition and increased left ventricular filling pressures.Inclusion of the prosthesis on the anterior leaflet cause mitral insufficiency detected during a routine follow up echo.The valve was implanted by full sternotomy concomitantly with three (3) cabg.As reported, first it was sutured the distal connections of the bypass (3 vessels), then the valve was implanted and finally it was connected the proximal end of the vessels to complete the bypass.After aortic valve implant procedure, there was no mitral insufficiency and aortic gradients and prosthetic area were correct.There were no sizing nor balloon inflation problems.No cardiac shunts or images suggestive of thrombi were evident.The patient was asymptomatic.During the redo surgery, it was observed that the aortic valve was correctly positioned, all three sutures were placed properly.Additionally no mitral insufficiency was observed by tee.No repair or replacement of the mitral valve was necessary.However, pericardium liquid with bacterial infection was confirmed by microbiological analysis and caused retraction of the tissue.There were no signs of infection.Valve was not analyzed for endocarditis.A 21mm inspiris valve was implanted in replacement.The patient presented renal complications and passed away.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18887276
• MDR Text Key: 337457363
• Report Number: 2015691-2024-01959
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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; Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male