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); Difficult to Open or Close (2921); Insufficient Information (3190)

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

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

H10: additional 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

It was learned through implant patient registry that a model 27mm 11500a aortic valve was explanted after an implant duration of 2 years, 9 months due to unknown reason.The explanted valve was replaced with a 29mm 3300tfx aortic valve.Patient was in recovery post procedure.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

H11: corrected data b3 - corrected date of event, d6b - field should be blank as device was not explanted.

Event Description

It was learned through implant patient registry and later through medical records that a model 27mm 11500a aortic valve underwent a valve-in-valve procedure after an implant duration of 1 years, 2 months due to moderate to severe aortic regurgitation, and aortic root dilatation.Tavr procedure was completed with a 29 mm non-edwards transcatheter valve.Per medical records, the patient presented in 2021 for cardiac clearance for knee surgery.Stress test and echocardiogram revealed inferior wall ischemia, moderate to severe aortic regurgitation, and aortic root dilatation.The patient underwent tavr utilizing a 29 mm non-edwards transcatheter valve on (b)(6) 2021.

Manufacturer Narrative

Leaflet immobility or leaflet restriction occurring over time, and not due to extrinsic physical interference, is a form of structural valve deterioration, which can result in significant regurgitation and/or stenosis.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including a history of cad s/p cabg x 1, hld and ckd 3.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.H11: corrected data d8 - "no" field should have been selected on initial fda report.

Event Description

It was learned through implant patient registry and later through medical records that a model 27mm 11500a aortic valve underwent a valve-in-valve procedure after an implant duration of 1 years, 2 months due to insufficient leaflets coaptation causing moderate to severe aortic regurgitation.The patient presented with heart failure.Tavr procedure was completed with a 29 mm non-edwards transcatheter valve.Per medical records, the patient presented in 2021 for cardiac clearance for knee surgery.Stress test and echocardiogram revealed inferior wall ischemia, aortic root dilatation, and moderate to severe aortic regurgitation secondary to insufficient leaflets coaptation.The patient underwent tavr utilizing a 29 mm non-edwards transcatheter valve on (b)(6) 2021.

• 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: 16788410
• MDR Text Key: 313753332
• Report Number: 2015691-2023-12487
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)241029(11)191031216574204
• 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,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: 11500A27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male