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

Model Number 11500A

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Aneurysm (1708); Aortic Valve Stenosis (1717); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Renal Failure (2041); Respiratory Failure (2484)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

On occasion rings or valves may be explanted with no evidence of malfunction and are otherwise performing as intended.In this case, it was reported that the patient¿s mitral regurgitation worsened after implantation of the subject device.Cardiopulmonary bypass was reinstated and the mitral valve was repaired.It was noted that the bypass time was extended and the patient developed renal and respiratory failure.The device is not available for evaluation per follow-up with the hospital.The root cause of the reported event cannot be conclusively determined; however, it appears that this event was likely due to patient and/or procedural related factors.There has been no indication or allegation of a device malfunction.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 23 mm aortic valve was explanted at implant for prophylactic purpose, but caused cardiac valve replacement complication. another 23 mm was implanted.  per medical records, patient presented with ascending aorta aneurysm, sub-valvular aortic stenosis and pannus, and moderate mitral regurgitation, and underwent ascending aorta replacement and aortic root enlargement, redo-avr, and mitral valve repair.After the first 23 mm valve was implanted, the surgeon noted profuse bleeding from the stj to graft anastomoses; it was decided to reapply cross-clamp and cardiac arrest was obtained without complications.An aortic tear below the suture line caused by friable aortic tissue was noted after aortic graft was opened.The tear was repaired with interrupted 4-0 prolene pledgeted sutures.After the patient was weaned from cardiopulmonary bypass and decannulated, tee showed severe mitral regurgitation secondary to malcoaptation.A decision was made to repair the mitral valve with a non-edwards ring.Later the mitral valve was tested and found to be competent.Again profuse bleeding from aortic annulus was noted.After reapplying cross-clamp and the aortic graft was opened, it was noted that there was an aorta to aortic annulus dissociation close to the left to non commissure, caused by poor quality aortic tissues.It was decided that a root replacement was required and the first 23 mm valve was removed.Another 23 mm valve was sutured to a 28 mm valsalva graft and a bentall procedure was performed.Bypass time was extended and patient developed renal and respiratory failure.Final tee demonstrated aortic valve with normal function, trace mitral regurgitation and no sam.Patient was transferred to icu.  patient was discharged on pod #23 in fair condition.     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

Corrected data: f10, h6.Reference capa-(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: 9318499
• MDR Text Key: 166320489
• Report Number: 2015691-2019-04210
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: 11500A
• Device Lot Number: R-19D1907
• 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: 63 YR