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

Model Number 11500A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/14/2023

Event Type  Injury  

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 and investigation that a patient with a 23mm 11500a aortic valve was explanted at implant due to annular perforation.A 25mm 11060 aortic valved conduit was implanted in replacement.Per medical records: the 23mm 11500a was implanted with no complications.After decannulation and while the skin was being closed the patient suddenly became hypotensive with myocardial failure.The patient was quickly converted to medial sternotomy, re-cannulated and instituted bypass.The valve was inspected, coronary ostia was unobstructed, the valve was removed, and there appeared to be perforation of the aortic root tissue.Tissue integrity was weak and required aortic root replacement with a 25mm 11060 avc.Post procedure myocardial recovery did not occur.Anterior wall function was not sufficient to separate from bypass and a cabg x2 was performed.The aortic avc was functioning normally.At this point the lungs were quite edematous and unable to wean from bypass due to hypoxia.Cpb was then converted to va-ecmo and the patient was transferred to the icu.On pod #1, the patient returned to the operating room for mediastinal re-exploration for postoperative bleeding and ecmo decannulation.Tee revealed very poor systolic lv function.The patient remained off ecmo for approximately 45 minutes, however, she was unable to maintain intravascular volume.Cardiovascular and pulmonary function were inadequate to support life, the patient was then pronounced deceased in the operating room.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

Updated sections: d4 expiration date and udi number, g3, g6, h4, h6 type of investigation, investigation findings, and investigation conclusions.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.The most likely cause is procedural and patient factors, including both perforation of the aortic root tissue and poor tissue integrity.

• 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: 18490018
• MDR Text Key: 332603510
• Report Number: 2015691-2024-00274
• Device Sequence Number: 1
• Product Code: LWR
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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: 63 YR
• Patient Sex: Female