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

Model Number 11500A

Device Problems Calcified (1077); Insufficient Information (3190); Patient Device Interaction Problem (4001)

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

Event Date 11/24/2021

Event Type  Injury  

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 11500a aortic valve implanted four (4) months, was explanted due to unknown reasons.The explanted device was replaced with a 23mm 11500a aortic valve.Per implantation data card, explant was not due to deficiency of the device.Patient post-operative status noted as in recovery.

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.Attempts to retrieve 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 implant patient registry received information a 25mm 11500a aortic valve implanted four (4) months, was explanted due to aortic valve endocarditis with evidence of distal embolization and calcification on leaflets.Patient presented to hospital approximately one (1) month prior to explant and was diagnosed with endocarditis of bioprosthetic valve.Patient experienced embolization of vegetation material to the distal left anterior descending.Vegetations were noted on the bioprosthetic aortic valve.The explanted device was replaced with a 23mm 11500a aortic valve.Per implantation data card, explant was not due to deficiency of the device.Patient also underwent mitral valve repair with a 32mm physio ii ring due to severe mitral regurgitation.The patient was transported to the intensive care unit in hemodynamically stable but critical condition.Patient was discharged to cardiac rehab.Patient report noted calcifications on each leaflet.

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.H11.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13102020
• MDR Text Key: 285760930
• Report Number: 2015691-2021-07098
• 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
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 87 KG