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

Model Number 8300AB

Device Problems Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Hemorrhage/Bleeding (1888); Pneumonia (2011); Renal Failure (2041); Septic Shock (2068); Cardiogenic Shock (2262)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).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.The device will not be returned to edwards for evaluation as it remains implanted in the patient.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.Multiple requests for additional information regarding this event have been performed.Based on the available information, the root cause of the event cannot be determined, however, patient factors may have contributed.If additional information is received a supplemental mdr will be submitted.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

Edwards lifesciences maintains an (b)(6) 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.Initial event information received from implant patient registry department.Through investigation of the reported event, it was discovered through medical record review, a patient implanted with a 25mm aortic valve had the device explanted the same day due to pvl caused by an crack in calcific aortic ¿ annulus wall.An aortic root and annulus repair was performed and a 23mm replacement valve was implanted; no further leaks were identified.Post-operative complications included acute on chronic renal failure (hd dependent); pneumonia; septic and cardiogenic shock.The patient was discharged on pod#20.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10007971
• MDR Text Key: 192212153
• Report Number: 2015691-2020-11713
• 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
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: 8300AB
• Device Lot Number: R-18C0960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR