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

Model Number 8300AB19

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Anemia (1706); Regurgitation (2259)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The device was not returned to edwards for evaluation as it was discarded.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.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.In this case it was reported the event was not due to device malfunction.Based on the information received the cause cannot be determined; however, patient factors likely contributed to the event.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.Edwards received information that this 19mm aortic pericardial valve, implanted approximately seven (7) months, was explanted due to paravalvular regurgitation (pvl).This device was originally implanted for mics aortic valve replacement to correct aortic stenosis.Although mild paravalvular regurgitation was observed and lactate dehydrogenase was elevated in the perioperative period, since the patient condition was getting stable, follow-ups were performed.However acute elevation of lactate dehydrogenase and anemia were observed during a half-year follow-up, so the patient became a candidate for a surgery.This device was explanted and replaced with a 19mm aortic valve with no adverse patient effects reported as a result of the valve replacement.The patient status was reported as ¿recovering¿ the condition of the valve at explant was reported as ¿the valve was not seating well and there was a space between the valve and the annulus.Paravalvular regurgitation was observed from a part of commissures of this valve¿.

Manufacturer Narrative

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

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9327521
• MDR Text Key: 166581102
• Report Number: 2015691-2019-04236
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036/S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: 8300AB19
• 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: 71 YR
• Patient Weight: 45