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

Model Number CDS0701-XT

Device Problems Positioning Failure (1158); Premature Activation (1484)

Patient Problem Unspecified Infection (1930)

Event Date 03/17/2023

Event Type  Injury  

Event Description

This will be filed to report a clip that deployed prematurely.It was reported that on (b)(6) 2023 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.The first clip was implanted successfully.A second clip was then advanced.It was noted that after performing multiple grasping attempts, the clip separated from the actuator mandrel and was only connected to the lock and gripper lines.Subsequently, the physician elected to real the clip back to the steerable guide catheter (sgc) tip and retract the devices through the septum.The physician then attempted to remove the clip and sgc from the patient.During this removal, the clip further detached and was left in the patients groin.The physician retrieved the clip and the procedure was concluded with a resulting mr of grade 2+.On (b)(6) 2023 the patient was admitted to the emergency department with an infected groin access site.No additional information was provided.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the reported information, it was further reported that the clip interacted with chordae and there was difficulty grasping experienced.It was also noted that imaging was challenging throughout the procedure.No additional information was provided.

Manufacturer Narrative

The reported premature activation, poor imaging, and positioning failure could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported positioning failure appears to be due to procedural conditions.The reported premature activation appears to be due to the observed broken actuator coupler.The bent and broken actuator coupler appears to be due to procedural conditions.A cause for the difficult imaging could not be determined.A cause for the reported infection could not be determined.Additionally, infection is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported removal of foreign body, hospitalization, and unexpected medical intervention are the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 16714938
• MDR Text Key: 313138574
• Report Number: 2135147-2023-01578
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• 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,Followup
• Report Date: 06/15/2023

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 Expiration Date: 05/18/2023
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20518R152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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: 1 MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 143 KG