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

Model Number 11500A

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

Patient Problem Blood Loss (2597)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

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.The device was not returned for evaluation, as the device return follow-up is ongoing.Minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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

Through review of information presented at the heart valve society meeting held in abu dhabi 2020 in the poster "initial experience with the inspiris bioprosthesis for valve replacement in patients with congenital heart disease.Spain" and the linked published article entitle "initial experience with the inspiris bioprosthesis for valve replacement in patients with congenital heart disease" by arribas et al 2020, the following event was identified as pertaining to an edwards valve: 1 patient with congenital heart disease was reoperated due to a moderate pvl after an unknown implant duration.Device implant position was unknown.

Event Description

Through review of information presented at the heart valve society meeting held in abu dhabi 2020 in the poster "initial experience with the inspiris bioprosthesis for valve replacement in patients with congenital heart disease.Spain" and the linked published article entitle "initial experience with the inspiris bioprosthesis for valve replacement in patients with congenital heart disease" by arribas et al 2020, the following event was identified as pertaining to a 23mm aortic valve: 1 patient with congenital heart disease was reoperated due to a moderate perivavular leak on pod #5. the pvl was corrected with new ticron stitches.There was no adverse event occurred on the patient.As reported, pvl was located in the non-coronary sinus and was caused by severe calcification of the native dysplastic aortic valve.

Manufacturer Narrative

  the device was not returned for evaluation, as it remains implanted.The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.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.

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: 9875961
• MDR Text Key: 193279547
• Report Number: 2015691-2020-11126
• 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,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: 11500A
• Device Lot Number: R-19G3964
• 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: 37 YR