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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple requests for additional information have been performed; however, the healthcare provider has not provided any additional details regarding this event.Although the reason for the explant is unknown, there has been no allegation of product malfunction or deficiency contributing to the event.The reported event cannot be confirmed with the available information.The root cause of this event remains indeterminable.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.No further actions are required at this time.

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.In this case, it was learned that an 8300ab 25 mm intuity elite aortic valve, implanted for 25 days, was explanted due to unknown reasons.The explanted device was replaced with a 3300tfx 23 mm bioprosthetic valve.No other details provided.

Manufacturer Narrative

Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.There are patient and technical related factors that may contribute to the development of pvl.In this case, there is insufficient information available to conclusively determine the root cause of this event.

Event Description

It was learned that an 8300ab 25mm intuity elite aortic valve, implanted for 25 days, was explanted due to perivalvular leak.This (b)(6) male has a past medical history significant for coronary artery disease as well as aortic and mitral valve pathologies.He recently underwent mechanical mvr and avr with the subject device.Cabg x2 was also performed.His postoperative course was complicated by pericardial effusion, as well as a perivalvular leak in both the mitral and aortic valves.Therefore, the patient returned for reoperation.The aortic valve was examined.The area of leak was noted to be around the native right/non-commissure.The explanted device was replaced with a 3300tfx 23mm valve.Redo-mvr was also performed.The patient was successfully weaned from cardiopulmonary bypass.Both valves appeared well-seated with no signs of perivalvular leak.There were no complications.He was transferred to the cvicu in critical but stable condition.

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: 7874946
• MDR Text Key: 120242264
• Report Number: 2015691-2018-03796
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: 8300AB
• 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: 50 YR