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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned through implant patient registry that a 23mm 11500a aortic valve was explanted after an implant duration of 4 months, 27 days due to unknown reason.The explanted valve was replaced with a 23mm 11500a valve.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.

Manufacturer Narrative

The device history record 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.Valve dehiscence is not a malfunction of the device.The most likely cause is patient factors, including reported fistula.

Event Description

It was learned through implant patient registry that a 23mm 11500a aortic valve was explanted after an implant duration of 4 months, 27 days due to dehiscence and paravalvular leak (pvl).The patient presented with dyspnea.The explanted valve was replaced with a 23mm 11500a valve.Per medical records, the patient presented with murmur, worsening volume overload, and dyspnea.Tee confirmed pvl along with distance of the bovine pericardial patch from the previous avr surgery.Intraoperatively, there was dehiscence of the aortic bioprosthesis from the left coronary sinus.The valve was removed.The previously sewn bovine pericardial patch had dehisced as well, with a fistula underneath the left coronary cusp to the la, that was also removed.Sutures with pledgets were placed on the ventricular side taking bite through the aorto-mitral curtain and up to the aortic annulus.The explanted valve was replaced with another 23mm 11500a valve.There was a small pvl underneath the left main.Given the complexity of the repair and the small size of the prior pvl the surgeon decided not to perform any intervention.The patient transferred out of the or in stable condition.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16325182
• MDR Text Key: 309057950
• Report Number: 2015691-2023-10680
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)260413(11)220414219279373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female