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

Model Number 11500A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hypoxia (1918)

Event Date 02/12/2023

Event Type  Injury  

Event Description

It was learned via the implant patient registry and medical records that an 11500a 21mm inspiris resilia aortic valve, implanted for five (5) days, was explanted due to dehiscence caused by annular patch detachment due to friable tissue.The patient presented with hypoxia.The patient is a known case of recent endocarditis.The explanted device was replaced with an 11500a 21mm inspiris resilia valve.The patient is s/p avr due to endocarditis and cad.On pod # 4 the patient developed hypoxia and required intubation.His tee showed a new vsd, and aortic perivalvular leak.He was taken back to or emergently.The surgeon noticed that the pericardial patch that was used to close the abscess cavity is now detached and have caused the newly implanted valve to dehisce from the annular tissue.Simultaneously, the patient had tvr utilizing a non-edwards valve and vsd closure.The patient tolerated the procedure well and was and transferred to the icu in a stable condition.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 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.

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.Through further investigation, it was determined that the root cause of this event was most likely cause is patient factors, including the annular patch detachment due to friable tissue of the patient.

• Brand Name: EDWARDS 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: 16588043
• MDR Text Key: 311737801
• Report Number: 2015691-2023-11752
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)260302(11)220303219168417
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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 Model Number: 11500A
• Device Catalogue Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male