MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART-VALVE

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problem Dyspnea (1816)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

Additional narratives surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that an unknown model aortic valve was disabled via a valve-in-valve procedure after an unknown implant duration due to regurgitation and perivalvular leak.The patient presented with dyspnea.A 23mm transcatheter valve was implanted successfully.

Event Description

It was reported that a 25mm aortic valve was disabled via a valve-in-valve procedure after an implant duration of 14 years, 8 months due to regurgitation and perivalvular leak.The patient presented with dyspnea.A 23mm transcatheter valve was implanted successfully.

Manufacturer Narrative

Updated b5 per new information received.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: NI
• Type of Device: REPLACEMENT HEART-VALVE
• 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: 16795903
• MDR Text Key: 313829412
• Report Number: 2015691-2023-12531
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/01/2023
• 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; Life Threatening; Hospitalization