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 Problem Insufficient Information (4580)

Event Date 05/15/2023

Event Type  Injury  

Event Description

Edwards received notification that a patient with an inspiris resilia valve model 11500a of unknown size underwent re-intervention for a valve-in-valve procedure after an implant duration of approximately six (6) years for unknown reason.

Manufacturer Narrative

No further information was available at the time of the reported event.The subject device is not available for evaluation as it remains implanted in the patient.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.

Manufacturer Narrative

Updated: h6 (investigation findings, investigation conclusions).H10 manufacturer narrative: based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Consequently, a definitive root cause cannot be conclusively determined.

Event Description

Edwards received notification that a patient with an inspiris resilia valve model 11500a of unknown size implanted in pulmonary position underwent re-intervention for a valve-in-valve procedure after an implant duration of approx.Six (6) years for unknown reason.No further information was available at the time of the reported event.

Manufacturer Narrative

Updated: b5 (describe event or problem).H10 manufacturer narrative: further information was received regarding the implant position (pulmonary).The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

Updated: b5 (event description), h6 (component code, device code, investigation findings, investigation conclusions).Added: a2 (age at time of the event), a3 (gender), b3 (date of event).A device history record (dhr) review was unable to be performed because the serial number of the valve is unknown.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards' valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.Leaflet immobility or leaflet restriction occurring over time can be attributed to structural valve deterioration and/or nonstructural dysfunction, which can be manifested as regurgitation and/or stenosis.Nonstructural valve dysfunction (nsvd) is any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nsvd refers to problems that do not directly involve valve components yet results in dysfunction of the prosthetic valve; such problems can include entrapment by pannus, tissue, or suture, malposition, patient prosthesis mismatch, thrombosis, or technical errors.Per edwards technical summary, structural valve deterioration (svd) can also lead to chronic central leaks over a period of time.Based on the information available, a definitive root cause cannot be conclusively determined; however, patient factors including implant position likely caused or contributed.There is no evidence to suggest an edwards manufacturing defect.

Event Description

Edwards received notification that a 25-y-o female patient with a 29 mm inspiris resilia valve model 11500a implanted in pulmonary position underwent re-intervention for a valve-in-valve procedure after an implant duration of eight (8) months due to severe valve dysfunction secondary to restricted motion of the anterior leaflet leading to pulmonary insufficiency.As reported, pulmonary insufficiency with anterior jet was observed after 6 months of implant duration.A 29mm transcatheter valve was implanted within the edwards surgical valve.As reported, no further information is available/can be provided by the hospital for this case.

• 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; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17287661
• MDR Text Key: 318826967
• Report Number: 2015691-2023-14470
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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: 10/18/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Female