MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-NTW

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

Mitral clip delivery system release failed.Clip not seated on valve, retracted with snare and removed.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside dr; santa clara CA 95054
• MDR Report Key: 16582434
• MDR Text Key: 311683228
• Report Number: 16582434
• 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: 03/07/2023,02/27/2023

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-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 20615R136
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: White