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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Product evaluation.Customer report of paravalvular leak could not be confirmed through visual observations.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.As received, leaflet 1 was cut, approximately 6mm long, near commissure 2.Edges of cut were straight and even.Mechanical damage marks were also observed on leaflet 1 near commissure 1 and appeared serrated.Sutures remained attached to the sewing ring around leaflet 3.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 and is not a result of device malfunction.There may be small pvls identified intra-operatively or post-operatively which do not require any intervention.Most cases of pvl noted intra-operatively are corrected with standard surgical techniques during the initial implant procedure and do not lead to serious injury or death.Events of pvl will be reportable if any of the following occur: there is an allegation that a serious injury or death is related to the intervention performed to treat the pvl (intra-operative valve exchange or standard surgical techniques); there is an alleged malfunction of the device that led to serious injury or death; there was intervention to treat the pvl performed after the initial implant surgery.In this case, there was no allegation of device malfunction; however, the annulus was reinforced with a patch and the valve was replaced with a smaller size valve throughout the intervention performed to treat the pvl.The device was returned for evaluation.The root cause of this event cannot be conclusively determined.The investigation is still in progress since the engineering evaluation is pending.A supplemental mdr will be submitted once the engineering evaluation is completed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this 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.Udi number: (b)(4).

Event Description

Edwards learned that a 21mm aortic pericardial valve was explanted at implant due to paravalvular leak.The procedure was avr+cabg.The device was originally implanted for aortic valve replacement to correct aortic stenosis.At implant, the surgeon removed the heavy calcification on the patient¿s native aortic annulus, and then the valve was implanted with no problem observed, however, paravalvular leak was detected by intraoperative echo.The 21mm valve was explanted and the annulus was reinforced with a patch, and then, replaced with a smaller 19mm valve while the patient was on bypass with no adverse patient events reported.The patient status was reported as ¿under treatment¿.There was no allegation of device malfunction.

Manufacturer Narrative

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

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9795317
• MDR Text Key: 194324786
• Report Number: 2015691-2020-10818
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 11500A
• Device Lot Number: R-19H4374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• 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: 84 YR
• Patient Weight: 45