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

Model Number 11500A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 08/21/2023

Event Type  Injury  

Event Description

Through implant patient registry it was learned a 25mm 11500a aortic valve was explanted after implant duration of six (6) months, due to unknown reasons.The explanted device was replaced with another 25mm 11500a aortic valve.Explant was not due to deficiency of the original device.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

Attempts to retrieve the device and additional information were unsuccessful.The cause of the event cannot be determined.

Event Description

Through implant patient registry and medical records, it was learned a 25mm 11500a aortic valve was explanted after implant duration of six (6) months, due to aortic valve endocarditis.The explanted device was replaced with another 25mm 11500a aortic valve.Explant was not due to deficiency of the original device.Patient was transferred to icu.Patient discharged on pod #7.Per medical records the patient presented with native mitral valve and bioprosthetic aortic valve endocarditis.The 25mm 11500a aortic valve on echo had good leaflet motion, but the leaflets edges were a bit shaggy in appearance.There was a lot of edema and swelling int he area of the noncoronary cusp strongly suggestive of an area of abscess.Upon inspection of the aortic valve, the left and right cusps were clearly attached with no problem, but the commissure between the right and noncoronary cusp and up under the noncoronary annulus was an area of annular abscess.There was also thick shaggy sessile vegetations on the right and non-leaflets of the prosthetic aortic valve.The 25mm 11500a aortic valve was explanted.The aortic abscess was then repaired with cormatrix.The explanted device was replaced with another 25mm 11500a aortic valve.The mitral valve was repaired with a 28mm cosgrove mitral ring.Patient was transferred to icu.Patient underwent pacemaker placement on pod # 3.Patient was discharged on pod #7.

Manufacturer Narrative

The cause of the event was due to patient factors/conditions.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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18692395
• MDR Text Key: 335185239
• Report Number: 2015691-2024-00957
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)260420(11)220421
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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: 70 YR
• Patient Sex: Female