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

Model Number 8300AB27

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2021

Event Type  Injury  

Manufacturer Narrative

Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.The subject device is not available for evaluation at this time.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 valve model 8300ab27 was explanted after an implant duration of four (4) days due to moderate-to-severe paravalvular leak at the level of the right coronary cusp.Reportedly, the surgeon performed a right anterior thoracotomy to implant the valve in a patient with a stenotic bicuspid native valve.No concomitant myomectomy was performed at the time of device implantation.Preparation and deployment were performed as per protocol.Intuity elite 1183 sizers were used and the cylindrical end and the replica end of the sizers were used when sizing.The selected size fit comfortably.On re-exploration, the surgeon noted that the guiding suture at the right coronary cusp level had broken, enabling the valve to descent down in the lvot at that level.The explanted device was replaced with a valve model 11500a29.

Event Description

Edwards received notification that this elite valve model 8300ab27 was explanted after an implant duration of four (4) days due to moderate-to-severe paravalvular leak at the level of the right coronary cusp.Reportedly, the surgeon performed a right anterior thoracotomy to implant the valve in a patient with a stenotic bicuspid native valve.No concomitant myomectomy was performed at the time of device implantation.The annulus was severely calcified.The debridement was not excessive but complete.Preparation and deployment were performed as per protocol.Intuity elite 1183 sizers were used and the cylindrical end and the replica end of the sizers were used when sizing.The selected size fit comfortably.On re-exploration, the surgeon noted that the guiding suture at the right coronary cusp level had broken, enabling the valve to descent down in the lvot at that level.The patient had no signs or symptoms prior to the procedure given that the patient was still recuperating from the heart surgery and not active (in bed in hospital).The explanted device was replaced with a valve model 11500a29.The patient was noted in perfect condition and discharged.

Manufacturer Narrative

Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Valve dehiscence is not a malfunction of the device.The device was not returned for evaluation as it was discarded.The device history record (dhr) review showed that this device passed all manufacturing inspections prior to release.No non-conformances were identified that could be related with the reported event.The cause of the event was likely related to procedural factors.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART- VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13008501
• MDR Text Key: 282259865
• Report Number: 2015691-2021-06847
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: 8300AB27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2020
• 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 Sex: Male