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

Model Number 11500A

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Congestive Heart Failure (1783); Regurgitation (2259); Organ Dehiscence (2502); Pseudoaneurysm (2605)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve 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 or from endocarditis.The device was not returned for evaluation, as the device return follow-up is still ongoing.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.

Event Description

It was reported via (b)(6) registry that a 29mm aortic valve was explanted and replaced with another 29mm valve on pod #6 due to root pseudoaneurysm caused by dehiscence.Patient was discharged home in improved condition on pod #13.Per medical records initially patient presented with aorta aneurysm and aortic valve regurgitation and underwent avr + ascending aorta replacement + bentall + laa procedure.Intra-operative finding included dilated aortic root, partially fused bicuspid r-l leaflets, thinned annulus at right and non-coronary cusps, and fragile tissue.Patient tolerated the procedure well without immediate complications.On pod #6 the patient underwent redo-avr + bentall procedure to repair root pseudoaneurysm due to annular dehiscence underneath noncoronary commissure and friable tissue.Intra-operative finding included subannular stitch partial tear at ncc near left-non commissure resulting in small pseudoaneurysm.  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

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: 10038787
• MDR Text Key: 191438183
• Report Number: 2015691-2020-11813
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• 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
• 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: 65 YR