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); Detachment of Device or Device Component (2907); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Endocarditis (1834); Insufficient Information (4580)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.If additional information is received a supplemental mdr will be submitted.The cause of the event cannot be determined.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.Edwards implant patient registry received information a 25mm aortic valve was explanted after implant duration of three (3) months, 16 days, due to unknown reasons.The explanted device was replaced with a 23mm aortic valve.Patient post-operative status was noted in recovery.

Manufacturer Narrative

H10.Additional manufacturer narrative: prosthetic valve endocarditis (pve) is a serious complication of cardiac valve replacement despite improvements in prostheses types, surgical techniques, and infection control measures.Pve is an endovascular, microbial infection occurring on parts of the valve prosthesis or on reconstructed native heart valves.Infection is generally categorized into early (usually less than 60 days postoperative) and late (greater than 60 days post-implantation).Late endocarditis occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not in any way related to the sterilization or packaging process of the device.Dental, genitourinary, and gastrointestinal manipulation are known causes of transient bacteremia, which can place a patient at risk for prosthetic endocarditis.Additional procedures placing patients at risk for prosthetic endocarditis include urethral catheterization, colonoscopy, barium enemas, and surgical procedures.If there were ever non-conformances in the sterility or packaging processes, they would most likely manifest in the early post-operative period.The cause of the event was likely due to patient factors/conditions.H11.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Edwards implant patient registry received information a 25mm aortic valve was explanted after implant duration of three (3) months, 16 days, due to prosthetic valve endocarditis with aortic root abscess, mild-to-moderate aortic insufficiency, and severe prosthetic valve stenosis.Patient presented with fever, chills, sweat, and weakness.She was found to have dental infection s/p extraction of 4 infected teeth.She was also found to have strep mitis bacteremia and prosthetic valve stenosis with large vegetation and root abscess.Given her root abscess and new onset of 1st degree av block urgent re-do avr was needed.On inspection of the aortic valve a few valve sutures were found to be detached from the aortic annulus of the right coronary cusp.The explanted device was replaced with a 23mm aortic valve.The patient was subsequently transferred to the postoperative cardiac surgical intensive care unit in critical condition.Patient was noted as discharged on post-operative day 18.

• 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: 12565221
• MDR Text Key: 274600938
• Report Number: 2015691-2021-05475
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 39 YR