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

Model Number 11500A

Device Problems Material Too Rigid or Stiff (1544); Structural Problem (2506); Incomplete Coaptation (2507); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); No Code Available (3191)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.Pannus can have both beneficial and harmful effects depending on the amount of growth.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Depending on the severity of the pannus, it may or may not require intervention.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 factors and the progression of the underlying valvular disease pathology 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 19mm valve implanted in pulmonary position was explanted and replaced with another 19mm valve after an implant duration of 8 months due to severe regurgitation and stenosis.Patient was discharged on pod #3.Per medical records, during the redo procedure there was severe neointimal ingrowth onto the valve leaflet, making it stiff and fixed in the open position.The echo prior to discharge showed a normal function of the bioprosthetic pulmonary valve with no stenosis or insufficiency.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 capa-20-00141.

• 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: 10236275
• MDR Text Key: 199894958
• Report Number: 2015691-2020-12430
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• 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; Required Intervention
• Patient Age: 17 MO