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

Catalog Number CDS0706-XTW

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

All available information was investigated, and the reported difficult to open or close (gripper actuation - single) and break (gripper line) was confirmed via returned device analysis.The reported positioning failure (leaflet grasping - clip not implanted) and difficult to remove (anatomy) could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information and the results of analysis, the reported difficult to open or close (gripper actuation - single), associated with a gripper¿s inability to raise, appears to be due to the gripper line break.The gripper line break appears to be due to the gripper interacting with the chordae.The reported difficult to remove (anatomy), associated with the clip implant interaction with chordae, was due to procedural circumstances while retracting the clip back to left atrium.The reported positioning failure (leaflet grasping - clip not implanted), associated with the inability to grasp, was due to challenging anatomy with leaflet restriction and tissue thickening.The reported tissue injury (chordal rupture) appears to be due to the clip implant interacting with chordae and the attempt to free from the chordae.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted and grasping was performed.However, the leaflets were unable to be grasped.When retracting the clip into the left atrium (la), the clip was caught in the chordae.After freeing the clip from the chordae, it was noticed that one of the grippers remained down while the gripper levers were retracted.Therefore, the clip was removed and replaced.While outside the anatomy, it was observed that one of the grippers lines had disconnected.An xt clip was inserted, but prior to grasping, a chordal rupture was observed.It was suspected to be caused by the xtw clip.The xt clip was then deployed, reducing mr to a grade of 3.No clinically significant delay in the procedure.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18548287
• MDR Text Key: 333313199
• Report Number: 2135147-2024-00303
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2024

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 Catalogue Number: CDS0706-XTW
• Device Lot Number: 30710A1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 52 KG