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

Catalog Number CDS0702-XTW

Device Problems Entrapment of Device (1212); Unintended Movement (3026)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 03/15/2024

Event Type  Injury  

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 on (b)(6) 2024, a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.One mitraclip xtw was implanted and the mr was reduced to grade 1-2.On 15mar2023, the posterior mitral leaflet (pml) was partially detached from the clip.The mr was recurrent at grade 4 and there was difficulty breathing upon exertion.A second clip intervention was performed.It was noted that visualizing the clip was challenging due to poor imaging and the patient's heavy breathing.The operator entered into the ventricle with no visibility, and the clip went into the medial chordae and was entangled.The pml was caught on the gripper.Troubleshooting was performed to free the gripper from the pml.To avoid possible rupture of the leaflet, it was decided to implant the clip where it was stuck.The mr was grade 0-1 after grasping, but the gradient was 12mmhg.Final attempts were made to free the clip and were unsuccessful.Another grasp was made and with a good mr result, but the gradient was high.Despite the gradient, the deployment sequence was started.After lock line removal, establish final arm angle (efaa) was performed and the clip opened to 100 degrees.The clip was closed again and deployed on both leaflets with chordae.The clip remained closed after deployment.The mr was reduced to grade 1-2.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All information was investigated, and the reported entrapment of device associated with the clip becoming caught in the anatomy appears to be related to procedural conditions associated with poor imaging.A cause for the unintended movement of clip opening during establish final arm angle (efaa) cannot be determined.Image resolution poor is related to patient and procedural conditions as visualizing the clip was reported to be challenging due to poor imaging and the patient's heavy breathing.A cause for the reported mitral stenosis cannot be determined; however, mitral stenosis is a known possible complication associated with mitraclip procedures.Unexpected medical intervention was a result 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: 19061088
• MDR Text Key: 339611853
• Report Number: 2135147-2024-01594
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)240930(10)31002R2068
• 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,Followup
• Report Date: 05/17/2024

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: CDS0702-XTW
• Device Lot Number: 31002R2068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention