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

Model Number XTR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  Injury  

Event Description

Mitral valve disengaged from shaft during mitraclip procedure, clip dislodged into the left ventricle leading to pt requiring sternotomy for mitral valve repair and annuloplasty.The 2 clips were used in the order i reported them the 1st failed, the 2nd clip was deployed using the same access across the septum as the 1st clip, it failed as well.The case was then turned into a thoracotomy valvuloplasty.

• Brand Name: MITRACLIP XTR
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 8755466
• MDR Text Key: 149977877
• Report Number: MW5087772
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2020
• Device Model Number: XTR
• Device Catalogue Number: REF: CD50601-XTR
• Device Lot Number: 90508U276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2019
• 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: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 96