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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2023

Event Type  Injury  

Event Description

The mitral clip became dislodged (however still connected to delivery system).Due to the shape of the clip at the time, physician was unable to bring clip back inside the delivery system to remove the device itself.The physician consulted ct(computed tomography) surgery as well as a colleague about best way to proceed.It was decided by all to perfuse patient with the help of surgery and perfusion.The device that malfunctioned was able to be successfully removed from the body.During the procedure patient did receive units of blood.Another device was quickly prepped and was successfully deployed in the mitra valve.The patient was intubated for procedure per protocol and left hybrid room intubated upon transport to icu.Prior to patient leaving, patient was taking off of pump and both groins successfully closed with hemostasis.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 17119348
• MDR Text Key: 317132825
• Report Number: MW5118351
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White