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

Model Number 11500A

Device Problems Calcified (1077); Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

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 reported 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 that a 23mm 11500a aortic valve was explanted after an implant duration of 2 years, 2 months due to unknown reasons.The explanted valve was replaced with a 29mm 3300tfx valve.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

Updated sections: b5, b7, g3, g6, h6 component code, health effect - clinical code, device code(s), and type of investigation.

Event Description

Through implant patient registry it was learned that a 23mm 11500a aortic valve was explanted after an implant duration of 2 years, 2 months due to severe stenosis and mild-moderate ai secondary patient prosthesis mismatch and endocarditis.The patient presented with chf.The explanted valve was replaced with a 29mm 3300tfx valve.Per medical records, the patient has a history of recent hospitalization for sepsis and endocarditis and now presented for an elective avr procedure.He underwent avr utilizing a 29mm magna ease aortic valve, cabg x1, and aortic root enlargement.The explanted valve showed degeneration, leaflets thickening, and valve thrombosis with no signs of active infection.Post cpb echo demonstrated normally functioning replacement valve with preserved ventricular function.The patient was taken back to the cvc icu in stable condition.The patient was discharged home on pod# 5 ct scan (in 2022) showed moderate calcification of bioprosthetic valve leaflets.

Manufacturer Narrative

Updated sections: d4 expiration date, g3, g6, h4, h6 component code, device code(s), type of investigation, investigation findings, and investigation conclusions the device history record 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.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.Intermediate, or late endocarditis (greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patient's body and is not in any way related to the sterilization or packaging process of the device.The most likely cause is patient factors.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.

Manufacturer Narrative

Manufacturer narrative: updated sections b5, g3, g6, h6 health effect - clinical code, device code(s), investigation findings, and investigation conclusions.Prosthetic endocarditis is a serious complication of valve replacement and repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset at 60 days or less postimplant) and late (onset greater than 60 days post-implant).Early-onset generally reflects contamination arising in the perioperative period; if there were ever non-conformances in the sterility or packaging processes, they would most likely manifest at this time.Late-onset occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not related to the sterilization or packaging process.In this case the onset was greater than 60 days post-implant.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.H11 corrected data: based on the new information received, this event is no longer considered reportable.

Event Description

Through implant patient registry it was learned that a 23mm 11500a aortic valve was explanted after an implant duration of 2 years, 2 months due to endocarditis causing severe stenosis and mild-moderate ai.The patient presented with chf.The explanted valve was replaced with a 29mm 3300tfx valve.Per medical records and additional information received later, the patient has a history of hospitalization in (b)(6) 2021 for sepsis and endocarditis which was treated medically and now presented with severe as and mild-moderate ai which resulted as a sequalae for endocarditis per medical opinion.He underwent avr utilizing a 29mm magna ease aortic valve, cabg x1, and aortic root enlargement.The explanted valve showed degeneration, leaflets thickening, and valve thrombosis with no signs of active infection.Post cpb echo demonstrated normally functioning replacement valve with preserved ventricular function.The patient was taken back to the cvc icu in stable condition.The patient was discharged home on pod# 5 ct scan (in 2022) showed moderate calcification of bioprosthetic valve leaflets.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16437551
• MDR Text Key: 310176040
• Report Number: 2015691-2023-11060
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)240603(11)200604217120497
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2024
• Device Model Number: 11500A
• Device Catalogue Number: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/06/2023; 04/11/2023; 04/11/2023
• Supplement Dates FDA Received: 04/03/2023; 04/11/2023; 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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: 56 YR
• Patient Sex: Male