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

Model Number 8300AB23

Device Problems Calcified (1077); Structural Problem (2506); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Aortic Dissection (2491); Blood Loss (2597)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).As reported, the issue occurred before implantation of the prosthetic valve.The aortic tear occurred during calcium debridement and it was repaired.The first device was successfully implanted; however, bleeding was observed from the tear and the surgeon elected to explant the valve to be able to repair the bleeding site again.The explanted valve was replaced with another 23mm edwards aortic valve successfully.There has been no allegation of device malfunction and/or deficiency.The root cause of this event was likely due to procedural related factors.The subject device is not available for evaluation as it was discarded.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.It was reported that a 23mm pericardial aortic valve was explanted at implant due to aortic tear.The explanted device was replaced with a 23mm pericardial aortic valve.Per the operative report, the valve was severely calcified and the aorta was severely involved with calcium with some cauliflower formation, which had to be endarterectomized.The aortic valve was resected and as mentioned, there was significant amount of calcium going down the curtain into the mitral leaflet, which was resected as conservation as possible.However, a tear occurred and this was repaired.The repair seemed fine and then the surgeon measured the valve to a 23mm valve and it was deployed at 4.5atm for 10 seconds.The valve was anchored with four sutures without pledget using cor-knot device.Both coronary ostia were clear and the aortotomy was closed.The patient came off bypass easily.The valve was sitting nicely and there was no leak.After the valve implantation, the patient had significant bleeding from back of the aorta, which the surgeon initially thought may have been a vent tear from the left atrium, but in retrospect was a tear from the debridement which had been repaired previously.The surgeon initially placed multiple sutures and obtained good hemostasis; however, upon closing, the patient suddenly started bleeding again and was reopened.The bleeding was coming from the muscle in the back, above the atrium typical of an annular tear.The patient was put back on bypass.The 23mm aortic valve was explanted and the small area of tear was repaired again, which was initially done at debridement.The surgeon believed there was still a small tear, which increased during blood pressure return, and the reason for leakage.The explanted valve was replaced with another edwards 23mm in supra-annular fashion due to patient's anatomy.The valve was well-seated with no leak.The patient received multiple products including 6 platelets, 6 ffp, and 10 red cells.It was also noted that left maze and cabg x2 were performed.The patient tolerated the procedure well and was transferred to the icu in stable condition.

Manufacturer Narrative

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: 7739879
• MDR Text Key: 115718527
• Report Number: 2015691-2018-03099
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 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: 02/04/2022
• Device Model Number: 8300AB23
• 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: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR