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

Model Number 11500A

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Fatigue (1849); Fever (1858); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 01/26/2024

Event Type  Injury  

Event Description

It was learned through implant patient registry that a patient with a 27mm 11500a aortic valve, was explanted after an implant duration of three (3) months due to unknown reason.The explanted valve was replaced with a 23mm 11060a valve.The patient is noted to be in recovery.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

H10: additional manufacturer narrative: the subject device is not available for evaluation, as the device status is unknown at this time.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

H10: additional manufacturer narrative: updated sections: h6 (component code, clinical code, device code, type of investigation).H11: corrective data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

It was learned through implant patient registry that a patient with a 27mm 11500a aortic valve, was explanted after an implant duration of three (3) months due to endocarditis.The explanted valve was replaced with a 23mm 11060a valve.Per medical records, patient was diagnosed with nonrheumatic aortic valve stenosis, presenting with fatigue, fever, and heart failure.Pvl, dehiscence and aortic root abscess resulted in emergent redo-avr.Intraoperatively, a large aortic annulus root abscess was noted to extend underneath the left coronary ostia.The 11500a valve was dehisced with only 2 stiches still intact.The valve was replaced with a 23mm 11060a valved conduit due to need for root replacement and coronary button re-implantation.The patient was transported to the icu in critical condition.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18849252
• MDR Text Key: 337070107
• Report Number: 2015691-2024-01648
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)260622(11)220623
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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
• 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; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male