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

Model Number 11500A

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

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

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was learned through implant patient registry that a 25mm 11500a aortic valve in aortic position was explanted after an implant duration of two (2) years, three (3) months due to unknown reasons.The replacement is a 25mm 11060a konect resilia 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

H10: additional manufacturer narrative: updated sections: h6 (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.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was learned through implant patient registry and medical records that a 25mm 11500a aortic valve in aortic position was explanted after an implant duration of two (2) years, three (3) months due aortic root abscess (endocarditis).The replacement is a 25mm 11060a konect resilia valved conduit and patient was transferred to a monitored bed in good condition.Unfortunately, the patient deceased on (b)(6) 2023 due to multi organ involvement.Per medical record, the patient had cardiopulmonary arrest due to multiorgan involvement including bacterial endocarditis, acute hypoxemic respiratory failure, and stroke due to bilateral cerebral infarctions also caused by bacterial endocarditis.Pathology report revealed aortic valve with adherent tissue demonstrating acute inflammation and fibrin deposition consistent with blood clot.The patient was recently discharged on (b)(6) 2023 for septic shock secondary to streptococcus mitis causing endocarditis on outpatient iv rocephin who follows with renown infectious disease was referred to the er on (b)(6) 2023 for worsening renal function.Patient was found to have prosthetic aortic valve endocarditis and he underwent aortic root replacement on (b)(6) 2023.On (b)(6) 2023, patient also underwent permanent pacemaker implantation for complete heart block.On (b)(6) 2023, patient was transferred to imcu since he did not show signs of clinical improvement in the setting of multi organ involvement.On (b)(6) 2023, the patient's family requested that he is placed in comfort care.The patient received morphine and benzodiazepine for discomfort and passed away.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18519863
• MDR Text Key: 332944289
• Report Number: 2015691-2024-00420
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)250421(11)210422217728350
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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: 55 YR
• Patient Sex: Male