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 Insufficient Information (4580)

Event Type  Injury  

Event Description

Edwards received a notification that a valve model 8300ab27 implanted in the aortic position was explanted after an implant duration of four (5) years and six (6) months due to paravalvular leak (pvl).Pledgets were not used.At time of initial implant, pvl was not apparent.The valve was successfully replaced with a 11500a25 valve.

Manufacturer Narrative

H3.Device evaluation: customer report of paravalvular leakage (pvl) was unable to be confirmed through visual observations.As received, the frame of the valve was deformed and pushed inward around commisure 1.X-ray demonstrated commisure 1 and 3 bent outwards and frame expanded.X-ray demonstrated minimal calcification on all three leaflets.Host tissue was moderate at the frame inflow.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.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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

Edwards received a notification that a valve model 8300ab27 implanted in the aortic position was explanted after an implant duration of four (4) years and six (6) months due to paravalvular leak (pvl).Pledgets were not used.At time of initial implant, pvl was not apparent.The valve was successfully replaced with a 11500a25 valve.

Manufacturer Narrative

Corrected data b5 (describe event or problem) added information to section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) h10: additional manufacturer narrative: 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 factors likely caused or contributed.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Host fibrous (pannus) tissue growth is not a malfunction of the device.The most likely cause is patient factors.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17818167
• MDR Text Key: 324266883
• Report Number: 2015691-2023-16176
• 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,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• 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; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male