MAUDE Adverse Event Report: ABBOTT LABORATORIES / ABBOTT VASCULAR ABBOTT MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problems Difficult to Remove (1528); Positioning Problem (3009); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  Injury  

Event Description

Patient undergoing a transcatheter mitraclip procedure with a mitraclip xtw.Multiple attempts to attach to posterior leaflet, finally successful but loc-line met resistance and could not be removed.Clip was released and procedure aborted.Fda safety report id# (b)(4).

• Brand Name: ABBOTT MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT VASCULAR
• MDR Report Key: 11343792
• MDR Text Key: 232903936
• Report Number: MW5099465
• Device Sequence Number: 1
• Product Code: NKM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00917U119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR