MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CORPONE EDWARDS LIFESCIENCES SAPIEN 3.29MM TAVR SYSTEM

Catalog Number 154667

Device Problems Inflation Problem (1310); Activation Failure (3270)

Patient Problems Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Chest Pain (1776); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 05/26/2022

Event Type  Death  

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Tavr equipment malfunction.The valve was positioned across the aortic valve, performed rapid ventricular pacing, and tried to deploy the valve.The balloon did not inflate.Required removal of both the valve and the delivery system.During removal, there was perforation of the subclavian artery.Vascular surgery and cardiothoracic surgery team performed emergency surgery to control the bleeding.During this time, he had a pea arrest with 3-4 minutes of cpr and gave code strength epinephrine.Determined that he would not survive other procedures to repair.Placed on comfort care.An 83-year-old male with history of coronary artery disease, non-stem i, history of pci, history of cabg, hypertension, chronic kidney disease, copd, who presented with chest pain, echo revealing severe aortic stenosis.

• Brand Name: EDWARDS LIFESCIENCES SAPIEN 3.29MM TAVR SYSTEM
• Type of Device: TAVR SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES CORPONE; edwards way; irvine CA 92614
• MDR Report Key: 16387264
• MDR Text Key: 309732544
• Report Number: 16387264
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2022

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 Catalogue Number: 154667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic