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

Model Number 11500A21

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Information (3190); Patient Device Interaction Problem (4001); Separation Problem (4043)

Patient Problems Unspecified Infection (1930); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned from the implant patient registry that a model 11500a 21mm aortic valve was explanted and replaced with a 11500a 19mm valve after an implant duration of 11 months due to unknown reasons.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.

Event Description

It was learned from the implant patient registry and medical records that a model 11500a 21mm aortic valve was explanted and replaced with a 11500a 19mm valve after an implant duration of 11 months, due to severe aortic insufficiency, dehiscence, and mild pannus.Patient transferred to icu in critical condition.Per medical records, patient presented with severe aortic insufficiency, severe mitral regurgitation, severe tricuspid regurgitation, and acute on chronic systolic heart failure, the 21mm 11500a aortic valve had partially dehisced and there was an old, healed abscess in the aortic root.The 21mm 11500a was explanted and replaced with a 19mm 11500a aortic valve.The patient also underwent mitral valve replacement with a 29mm mitris valve and tricuspid valve repair with a 28mm medtronic annuloplasty ring.Patient's cardiac function was sluggish on high inotropic support; therefore, the patient was separated from cardiopulmonary bypass and went straight to ecmo balloon pump and chest was left open.The patient was left intubated and transferred to the cardiac intensive care unit in critical condition.Pathology report: pericardial bioprosthetic aortic valve with mild pannus formation and possible 0.1 cm perforation.

Event Description

It was learned from the implant patient registry and investigation that a 21mm 11500a aortic valve was explanted and replaced with a 19mm 11500a valve after an implant duration of 11 months, due to partial dehiscence, severe aortic insufficiency.Path report showed small possible perforation.Per medical records, the patient presented with severe aortic insufficiency, severe mitral and tricuspid regurgitation, and acute on chronic systolic heart failure nyha iii, ef 30-40%.She underwent emergency surgery for mvr with mitris valve, tricuspid valve repair with medtronic tri-ad band, and redo avr.Intraoperatively, the 21mm 11500a aortic valve had partially dehisced and there was an old healed abscess in the aortic root.The valve was explanted, and aortic root was reconstructed with pericardial patch and to close the old abscess.The valve was replaced with a 19mm 11500a aortic valve.At the completion of the procedure there was very poor biventricular function and ecmo was initiated to separate from bypass.The chest was left open, and the patient transferred to the cicu in critical condition.On pod #9, the patient returned to the or for removal of ecmo and returned to the icu.On pod #12, return to the or for bilateral pectoralis muscle flap chest closure, the patient tolerated the procedure well.Hospital pathology report: pericardial bioprosthetic aortic valve with very mild pannus formation, no thrombi, vegetations, or cuspal tears are identified.A small possible perforation is present measuring 0.1cm in diameter (gross exam only).

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.Device dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of inadequate device 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 the healed abscess in the aortic root that was repaired with a pericardial patch.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17673739
• MDR Text Key: 322546431
• Report Number: 2015691-2023-15674
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)260309(11)220310219056476
• 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: 10/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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: 56 YR
• Patient Sex: Female