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

Model Number 11500A

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Laceration(s) (1946); Mitral Regurgitation (1964)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

The heart is a multivalvular system with heart valves function to promote coordinated forward blood flow during the cardiac cycle.Repairing or replacing one valve might affect the function of another valve by changing the heart structure and/or the hemodynamics.Additional unplanned intervention might be required to restore the normal forward blood flow.The potential for serious injury is not remote.These events will reportable if unplanned surgical/percutaneous intervention is indicated or performed as a result of cardiac valve replacement/repair complications, examples include: native valve regurgitation, left ventricular outflow tract (lvot) obstruction, systolic anterior motion (sam) of the mitral valve¿etc.In this case the patient developed an anterior mitral leaflet perforation and mitral regurgitation 9 days post avr and underwent an unplanned redo avr.The potential of risk in not remote.The device was not returned for evaluation, as it is unavailable for return per follow-up with hospital.The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.Udi number (b)(4).

Event Description

It was reported via patient registry that a 27mm aortic valve was explanted and replaced with a 25mm valve after an implant duration of 9 days due to repair an anterior mitral leaflet perforation and mitral regurgitation.The patient was discharged home in stable condition on pod #4.Per medical records the patient initially presented with non-edwards prosthetic valve restenosis and underwent redo-avr + cabg using the 27mm valve.Post-implant this valve was noted to have good function and the patient was brought back to the icu in stable, but critical condition.The follow-up echo showed what appeared to be a small hole underneath the aortic valve suture line causing a significant mitral regurgitation with a mitral fistula.On pod #9 patient underwent a redo-avr + patch closure of mitral valve fistula + annular enlargement of the aortic root.Intra-op finding includes that the whole aortomitral curtain was separated.This was repaired by using a pericardial patch and sutured with 4-0 prolene, and aortic annular enlargement using a pericardial patch and placement of a 25 mm valve.Post-implant good function of the mitral valve was noted.There was no evidence of mitral regurgitation or any paravalvular leak of the aortic 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

H10: additional manufacturer narrative.Updated h6 per new information received.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10322260
• MDR Text Key: 202180067
• Report Number: 2015691-2020-12690
• 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,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• 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; Required Intervention
• Patient Age: 66 YR