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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Thrombosis (2100)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (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.If additional information is received a supplemental mdr will be submitted.Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Ppm has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.The cause of the event was likely due to patient and procedural factors.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

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.It was learned via implant patient registry that a 23mm aortic valve was explanted after an implant duration of seven (7) months due to severe aortic stenosis, severe aortic regurgitation, large paravalvular leak (pvl), dehiscence, patient prothesis mismatch, and thrombus.The explanted valve was replaced with a 27mm aortic valve.The implantation data card indicated that the device explant was not due to deficiency of the original device.Per the medical records, a cabg x1 revision was performed.Notably, there was poor tissue quality secondary to long-term steroids.The valve was significantly dehisced, and there was significant thrombus along the valve in the left to non-sinus.The valve was removed.Upon evaluation of the aortic root, it looked as if the valve was slightly small for the true aortic root size.There was destruction, particularly along the left sinus, with tear into the muscle.Simple placement of sutures were used to repair what was possibly a root abscess.The annulus was resized to a 27mm valve.The patient was weaned from cardiopulmonary bypass.Tte confirmed a well-seated valve with trace pvl on the level of the left sinus.The patient was transported to the cicu in stable condition.The patient's postoperative course was complicated by chb and a permanent pacemaker was implanted on pod #2.The patient was discharged home with home health services on pod #8.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10877619
• MDR Text Key: 217680663
• Report Number: 2015691-2020-14555
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 95