MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0706-XTW

Device Problems Defective Device (2588); Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

Elderly male with history of cabg x 4 (coronary artery bypass graft) and severe mitral and tricuspid regurgitation.Procedure: mitral clip.After the mitral clip was in the body, it malfunctioned and would not open and close properly.The mitral clip became stuck on the sheath.After some time, the mitral clip was freed and removed from the patient- without known harm.Per physician, the mitraclip g4xtw malfunctioned that caused the steerable guide to become damaged.The patient received a new system including sheath and clip.Delay in procedure.Patient discharged day 2.Speculation of physician that there was a control issue with the white knob on the mitral clip- could have caused the not opening and shutting.Manufacturer response for steerable guide catheter, abbot (per site reporter).Will obtain.Manufacturer response for mitral clip, mitraclip g4 xtw (per site reporter).Will obtain.

• Brand Name: MITRACLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 177 county road b east; saint paul MN 55117
• MDR Report Key: 17134812
• MDR Text Key: 317237438
• Report Number: 17134812
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2023

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: Health Professional
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30208R1062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male
• Patient Weight: 83 KG