MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2016

Event Type  Death  

Event Description

Through review of medical article " rapid-deployment aortic valve replacement in a real-world all-comers population", the following event was identified as pertaining to an edwards device: nine patients with valves model edwards intuity 8300ab of unknown sizes implanted in aortic position died.As reported, the death was related to the valve.

Manufacturer Narrative

H11: additional manufacturer narrative: this is one of three manufacturer reports being submitted for this article.Refer to medwatch number (b)(4) for events within the same article.The date of the event is unknown; however, according to the article, the study period was from (b)(6) 2016 to (b)(6) 2021.Thus, the first day of the reported study period ( (b)(6) 2016) was used in field b3 as date of event.Article citation: yun t, kim kh, sohn sh, kang y, kim js, choi jw.Rapid-deployment aortic valve replacement in a real-world all-comers population.Thorac cardiovasc surg.2023 oct;71(7):511-518.The device was not returned for evaluation, no details regarding what issue warranted the intervention, or what comorbidities the patient had, were provided.Attempts to retrieve the device and additional information were unsuccessful.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.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

The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The device was not returned for evaluation, no details regarding what issue warranted the intervention, or what comorbidities the patient had, were provided.Attempts to obtain additional information were unsuccessful.An ifu review is unable to be performed, as no details regarding failure mode of the device were provided.The cause of the event cannot be determined.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19104058
• MDR Text Key: 340109417
• Report Number: 2015691-2024-02832
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Death