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

Model Number 8300AB25

Device Problems Calcified (1077); Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Failure of Implant (1924); Failure of Implant (1924); Tachycardia (2095); Tachycardia (2095); Blood Loss (2597); Blood Loss (2597)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus.The most common reason for pvl is inadequate debridement of a calcified annulus or attempted implant with improper valve seating.Pvl is not a result of device malfunction.There may be small pvls identified intra-operatively or post-operatively which do not require any intervention.Most cases of pvl noted intra-operatively are corrected with standard surgical techniques during the initial implant procedure and do not lead to serious injury or death.In this case, the patient required intervention due to perivalvular leak after an implant duration of two (2) months.There was no reported malfunction of the device.It was reported that there was residual significant calcification of the annulus, which had not been debrided in the initial surgery.As such, the valve was unable to be directly anchored to the annulus on either side of the rim of the residual calcification resulting in pvl.The root cause of this event was most likely due to procedural related factors from the initial surgery.The subject device has not been returned for evaluation.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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

It was reported that a 25mm pericardial aortic valve was explanted after an implant duration of two (2) months due to severe paravalvular leak (pvl) and significant aortic insufficiency (ai).The surgeon observed a ridge of calcification where the 4th closure stitch between the right coronary and left coronary struts was placed to address pvl at the original implant procedure.The explanted valve was replaced with a 27mm edwards pericardial aortic valve.Per medical records, the patient had a 50% lad lesion as well as a 99% rpda lesion, which were left ungrafted for unknown reasons.The paravalvular leak was very large and appeared to involve almost half of the of circumference of the valve, extending from the area of the placement of the repair suture and extending both towards non- as well as the left cusp.The 25mm valve was explanted.Upon inspection of the residual aortic annulus, there appeared to be two areas of residual significant calcifications of the annulus, which had not been debrided during the first operation.The first one appeared to be in the area of the paravalvular leak and it was most likely the cause of the paravalvular leak since the valve was unable to be directly anchored to the annulus on either side of the rim of the residual calcification.The surgeon removed the calcified area.The annulus was sized to a 27mm pericardial aortic valve and the valve was implanted successfully.Intraoperative tee showed a well-seated valve without evidence of paravalvular leak.It was also noted that cabg x2 was performed.The patient tolerated the procedure well and was transferred to the icu in stable condition.Post operatively, the patient experienced significant bleeding from his chest tubes.The patient received in total of 10 units prbcs, 4 units platelets, 9 ffps, 2 cryos, methylene blue and ddavp.He also required high doses of vasopressors.The bleeding tapered off without additional intervention.The patient experienced one episode of wide complex tachycardia after transfer to step down unit that resolved without intervention.His rhythm remained stable for the remainder of his stay.The patient continued to progress well and was discharged home on pod #7.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7739457
• MDR Text Key: 115705901
• Report Number: 2015691-2018-03092
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 86