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

Model Number 11500A

Device Problems Gradient Increase (1270); Structural Problem (2506); Incomplete Coaptation (2507); Unintended Movement (3026); Material Split, Cut or Torn (4008)

Patient Problems Endocarditis (1834); Failure of Implant (1924); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Sepsis (2067); Thrombus (2101); Stenosis (2263); Regurgitation, Valvular (2335); Pseudoaneurysm (2605)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4).The device was not returned to edwards for evaluation.The device history record (dhr) 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 thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve/ring.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.In this case, the patient required medical intervention to treat thrombosis.A manufacturing related issue was not identified.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a patient with a 29mm valve implanted in pulmonary position for nine months was treated with anticoagulant for pulmonary valve thrombus.The valve was explanted after an implant duration of ten months due to culture negative endocarditis, sepsis, torn leaflet, moderate-severe stenosis, eccentric regurgitation, and rvot and main pa pseudoaneurysm.A 27mm valve was implanted in replacement.The patient was discharged on pod #6 in stable condition.The patient had a new onset of fevers, myalgias, and sore throat after an implant duration of six months.She was diagnosed with culture-negative endocarditis and sepsis after an implant duration of eight months and treated with antibiotics.Echo showed free pulmonary valve regurgitation with multiple clots, stenosis, and possible pseudoaneurysm.The patient was re-hospitalized after an implant duration nine months.The patient was noted to have worsening rv dysfunction and a pseudoaneurysm of the rvot/mpa.Her blood cultures remained negative.She was started on anticoagulants for her pulmonary valve thrombus.After an implant duration of ten months, the patient underwent redo pulmonary valve replacement with a 27mm valve and redo reconstruction of the rv outflow tract.Echo showed her new valve was functioning very well.The patient was transported to cvicu in a stable but critical condition.The patient was discharged on pod #6 in stable condition.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10155150
• MDR Text Key: 195230593
• Report Number: 2015691-2020-12173
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: 11500A
• 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; Life Threatening; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 58