MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; TISSUE, HEART-VALVE

Model Number 11500A

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Congestive Heart Failure (1783); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

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.Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.A manufacturing related issue was not identified.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received information that a 19mm aortic pericardial valve, implanted approximately four (4) months, was explanted due to paravalvular leak secondary to valve dehiscence.The device was originally implanted for aortic valve replacement to correct aortic stenosis.At implant, severe calcification was observed from thoracic aorta to abdominal aorta.The patient¿s aortic annulus was narrow, and it had become hardened due to severe calcification.The 19mm valve could be used for this patient since the it was just size.After implant, mild regurgitation was observed, but the surgery was completed without any problem, and the patient was discharged from the hospital.After an approximately four (4) months from the surgery, the patient was admitted to the hospital due to heart failure, and paravalvular leak (pvl) and ventricular septal perforation (vsp) were detected by echo.Four (4) days after being admitted, the device was explanted and replaced with a non-edwards mechanical valve.Upon the valve explant, pvl due to valve and patient tissue dehiscence under the right coronary artery ostium was observed.After the surgery, right heart failure occurred when the patient was in icu.The patient¿s condition got worse and the patient eventually expired due to multiple organ failure.The detail of postoperative course was not provided from the doctor.The device was discarded at the hospital.The doctor commented that it was unknown whether this event was device related.Multiple cardiac surgical procedure: ventricular septal perforation closure at explant.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10246222
• MDR Text Key: 198707548
• Report Number: 2015691-2020-12440
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/13/2020

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: 10/16/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 74