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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Separation Problem (4043)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

Through implant patient registry it was learned a 27mm 11500a aortic valve implanted five (5) months was explanted due to unknown reasons.The explanted device was replaced with a 29mm 11060a aortic valved conduit.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

The cause of the event was most likely due to patient factors/conditions.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Through implant patient registry and investigation it was learned a 27mm 11500a aortic valve implanted five (5) months was explanted due to propionibacterium acnes endocarditis.The explanted device was replaced with a 29mm 11060a aortic valved conduit.Per medical records, the patient presented with acute heart, respiratory, and renal failures.Due to fever and elevated wbc, blood cultures were sent for concern of underlying abscess/endocarditis.Iv antibiotics were initiated.Echo showed aortic valve rocking with moderate-severe paravalvular regurgitation and evidence of dehiscence.The patient underwent redo avr with 29mm avc, redo ascending aorta replacement.The valve was mostly dehisced, there was extensive pannus below the valve, this was debrided, and cultures was taken.Post implant of the avc, there was no aortic insufficiency.The patient was transferred to the intensive care unit in stable condition.Or cultures were positive for p.Acnes.The patient was discharged home with iv antibiotics on pod #7.Pathology report: bioprosthetic aortic valve cusp with histiocytic reaction and reendothelialization.

Event Description

Through implant patient registry and medical records, it was learned a 27mm 11500a aortic valve implanted five (5) months was explanted due to severe paravalvular leak (pvl) and dehiscence.The explanted device was replaced with a 29mm 11060a aortic valved conduit.Per medical records, the patient presented with suspected endocarditis, vf arrest, severe valvular cardiomyopathy, severe paravalvular leak (pvl) and a residual 5.0 cm aortic root aneurysm.Echo demonstrated severe aortic pvl with rocking prosthesis and stenosis.Upon inspection of the 27mm 11500a aortic valve, it was found to be mostly dehisced and easily excised.There was extensive pannus formation below the prosthesis, this was debrided.A 29mm 11060a aortic valved conduit was then implanted securely with horizontal pledgeted mattress everting sutures incorporating the annulus.The patient was transferred to the intensive care unit in stable condition.Pathology report: bioprosthetic aortic valve cusp with histiocytic reaction and reendothelialization.

Manufacturer Narrative

Added information to b5, b6, b7, h6.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18489039
• MDR Text Key: 332603439
• Report Number: 2015691-2024-00270
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male