MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MITRACLIP¿; MITRAL VALVE REPAIR DEVICES

Model Number CDS0706-XTW

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  Injury  

Event Description

A transesophageal echocardiogram done, impella inserted, mitraclip device inserted, device malfunctioned and would not release from the device.Physician deployed in body, attempted to remove, however, cut down performed to successfully remove device.Additional mitraclip used for procedure.

• Brand Name: MITRACLIP¿
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 17859887
• MDR Text Key: 324781131
• Report Number: 17859887
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2023

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?: Yes
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30711R1044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Date Report to Manufacturer: 10/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA