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

Model Number CDS0601-XTR

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 04/17/2019

Event Type  malfunction  

Event Description

Md attempted to grip leaflet with device, device gripper failed.Md removed system and inserted new one.Pt required impella (a ventricular support device) and pressors during event.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3885 bohannon drive; menlo park CA 94025
• MDR Report Key: 8653365
• MDR Text Key: 146497635
• Report Number: 8653365
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/22/2019

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: No Information
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90221U178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA