MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0702-XTW

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a mitraclip procedure was performed to treat a mixed mitral regurgitation (mr) with grade of 4, posterior flail, prolapsed posterior leaflet, dilated left atrium.The mitraclip system was prepared as per instruction for use (ifu) and functioned as intended.During the procedure, the clip was inverted for re-alignment and attempt to get back into the atrium.Echocardiogram showed that one gripper did not raise and remained at 120 degrees.During re-positioning, the clip was caught in chordae and was able to be freed with standard troubleshooting but was noted to be difficult.It was noted that the cds was curved to approximately 110 degrees.After removal, the clip was inspected, showing that the gripper line was not on the gripper but had been pulled into the system.A replacement device was used to complete the procedure.Two clips were implanted, reducing mr to grade 3.There was no clinically significant delay in the procedure and no adverse patient effects.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18952612
• MDR Text Key: 338305936
• Report Number: 2135147-2024-01298
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30912R1082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER