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

Model Number 11500A21

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2024

Event Type  Injury  

Event Description

Through implant patient registry it was learned a 21mm 11500a aortic valve implanted two (2) years, six (6) months, was explanted due to unknown reasons.The explanted device was replaced with a 23mm 11060a aortic valved conduit.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

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Through implant patient registry and medical records, it was learned a 21mm 11500a aortic valve implanted two (2) years, six (6) months, was explanted due prosthetic aortic valve strep anginosus and staph hominis endocarditis with severe aortic regurgitation and dehiscence.The explanted device was replaced with a 23mm 11060a aortic valved conduit.Per medical records, the patient presented with altered mental status and felt unwell.Blood cultures have grown strep anginosus and staph hominis.Tee revealed prosthetic valve vegetation with large abscess involving lvot and rvot.Upon inspection of 21mm 11500a aortic valve it was noted to have dehisced partially.The 21mm 11500a aortic valve was explanted and root replacement was performed with a 23mm 11060a aortic valved conduit.Patient was transferred to the cardiothoracic surgery icu in stable condition.

• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19181297
• MDR Text Key: 341039009
• Report Number: 2015691-2024-03141
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)250407(11)210408
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2021
• 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: Female