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

Model Number CDS0701-XT

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 03/19/2020

Event Type  Injury  

Event Description

Dr.Was performing a mitral clip procedure and when removing the mitral clip he was unable to deploy.Only half of the clip was engaged in the steerable guide catheter.When removing the steerable guide catheter, the clip opened and became lodged in the femoral vein.The patient experienced significant hemorrhage.Cardiac and thoracic surgeon was called in to do an open cut down and removal of clip.Almost all the blood loss occurred while trying to explore the wound and gained proximal and distal control on the femoral vein and once this was performed the foreign body could be removed.There was a defect about 1.5 cm in diameter in the vein.It was not able to be repaired primarily but was repaired with a pericardial patch.Hemostasis was good at the conclusion of the procedure.There was a small amount of thrombus within the lumen of the vein which was removed when the foreign body was removed.Patient was discharged to the cicu.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 11648188
• MDR Text Key: 244894851
• Report Number: 11648188
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: (01)08717648230981
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

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
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 00818U214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29565 DA
• Patient Weight: 121