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); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Insufficient Information (4580)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve additional information and the device 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.

Event Description

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.Through implant patient registry, it was reported that a patient with a 25mm 11500a aortic valve was explanted after an implant duration of 3 years, 9 months due to unknown reason.The explanted valve was replaced with a 23mm 11060a konect resilia valve conduit.The implantation data card (idc) indicated that concomitant coronary artery bypass was performed.The patient was in recovery post operatively.

Manufacturer Narrative

H10.Additional manufacturer narrative: added information to b5.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

There was nothing wrong with the surgeon valve it was explanted due to aortic root aneurysm.

Manufacturer Narrative

H10.Additional manufacturer narrative: added information to b5, h6.

Event Description

Through implant patient registry, it was learned that a patient with a 25mm 11500a aortic valve was explanted after an implant duration of 3 years, 9 months due aortic root aneurysm.The explanted valve was replaced with a 23mm 11060a valve conduit.Per follow-up with the rep the reintervention was d/t a leaking valve and there was no issue with the device.Per medical records, the patient presented with massively enlarged aortic root aneurysm.The patient underwent redo aortic root replacement (bentall procedure) with a 23mm 11060a avc.A cabrol procedure with hemashield graft was performed due to the ostia to left main coronary artery has extremely poor tissue.There were no complications.

• 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15121674
• MDR Text Key: 296775027
• Report Number: 2015691-2022-07045
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)200214
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male