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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Tissue Breakdown (2681); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device and additional information is in process.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 notification that a 8300ab23 valve model implanted in the aortic position was explanted after an implant duration of 16 days due to paravalvular leak caused by the valve size being too small and leading to severe aortic insufficiency.Reportedly, at the end of the initial procedure, the patient had a slight leak which worsened over the days until causing heart failure to the patient due to insufficiency.Thus, customer decided to explant the valve.Reportedly, the choice of the first valve size was not correct.During explant procedure, it was noticed that on the side where the leak was, the valve had slipped into the ventricle.A 25mm inspiris valve was implanted in replacement.The patient was noted as to be discharged home.

Manufacturer Narrative

Added information to section b5 (describe event or problem), d4 (serial number), h6 (health effect - clinical code), h6 (device code(s)), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) corrected data h6 (device code(s)): "1583 - inadequacy of device shape and/or size" removed.H10: additional manufacturer narrative: the subject device was not available to be returned for evaluation and no imaging or medical records were provided.Dhr review was performed, and no relevant non-conformances were identified.A lot history review identified no similar incidents.It was reported that there was significant debridement, which caused a small lesion of the annulus, leading to periprosthetic leak.Possible contributors to the valve migration include but are not limited to potential dehiscence from the patient tissue, difficulties sizing after debridement, and potential under expansion of the frame.Based on the information available, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.An edwards defect has not been confirmed.

Event Description

Edwards received notification that a 8300ab25 valve model implanted in the aortic position was explanted after an implant duration of 16 days due to paravalvular leak caused by the valve moving and slipping into the ventricle leading to severe aortic insufficiency.Reportedly, during index procedure, a 23mm valve was intended to be implanted.However, after a significant debridement, it was decided to implant a 25mm intuity valve.As reported, at the end of the initial procedure the patient had a slight leak which worsened over the days until causing heart failure to the patient due to insufficiency.Thus, surgeon decided to explant the valve.During explant procedure, a small lesion of the annulus was observed, which according to the clinician occurred during the first decalcification phase and lead to a significant periprosthetic leak.A 25mm inspiris valve was implanted in replacement and through continuous suturing, they carried out a small remodeling of the annulus to repair the small lesion.The patient was noted as to be discharged home.

• 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; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18000902
• MDR Text Key: 326445970
• Report Number: 2015691-2023-17047
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Sex: Male