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

Lot Number 80625U151

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 09/26/2018

Event Type  Injury  

Event Description

Mitraclip implant was placed per surgery but did not deploy as expected.Required a right common femoral vein cut down and retrieval of the malfunctioning device.

• Brand Name: MITRACLIP XT
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 7938534
• MDR Text Key: 123138450
• Report Number: MW5080372
• Device Sequence Number: 0
• Product Code: NKM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2019
• Device Lot Number: 80625U151
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR