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

Catalog Number CDS0706-NTW

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult to Open or Close (2921); Activation Failure (3270)

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

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 4+, pressure gradient of 3mmhg, stiff anterior leaflet, and restricted posterior leaflet, measuring 8-9cm.Transseptal puncture was achieved with height of around 4.7cm.An ntw clip was advanced and oriented medial to a2/p2.On the first grasp, the anterior leaflet could not be visualized.The grippers were raised and checked 3d.The clip had rotated 90 degrees.The orientation was fixed by clocking the handle and went for second grasp.At this time some tension was felt on the catheter and decided to invert and come back to reset in the atrium.It was noticed that the clip was caught in the anterior leaflet.After multiple attempts of freeing the clip, the clip was unable to come loose off of the anterior leaflet.At this point the anterior was fully inserted in the clip, but the posterior leaflet could not be reached due to the tension on the catheter.It was noticed that the clip would not open more than 60 degrees.It was decided to deploy the clip in only the anterior leaflet, as the catheter was not responding a/p directions.During deployment, due to tension on the catheter, the gripper line did not come out.As part of the troubleshooting steps, the gripper lines were accessed, and they immediately snapped back into the device.It was decided to open the patient¿s chest to retrieve the clip and disconnect from the gripper line.Once the chest was open, the clip was observed to be completely entangled in a very dense, thick chords (at p2 segment).The clip was removed.The patient had a mitral valve replacement surgery and a coronary graft.Patient remained very stable throughout the procedure, so this surgery was not ¿emergent¿.The patient is reported to be stable and recovering.This issue reportedly caused a clinically significant delay, but the delay did not result in adverse patient sequelae.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned for analysis.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 identified no similar complaints reported from this lot.The investigation determined the reported difficulty grasping the leaflets was due to the reported poor image resolution.The poor image resolution was due to stiff anterior leaflet and restricted posterior medial leaflet.The reported inability to open the clip and inability to deploy the clip appear to be related to the reported entrapment of device (clip caught on anatomy).The entrapment of device appears to be due to patient morphology/pathology (thickened chords).The reported surgical intervention, removal of foreign body, unexpected medical intervention, and delay of treatment/therapy were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Imaging review: one (1) fluoroscopic still image was provided (video taken on a personal device of a fluoroscopy monitor).The cds is under straddled with the distal sleeve radiopaque tip ring located inside the sgc proximal to the guide tip ring.The delivery catheter (dc) shaft is extended ~ 1 - 2 cm from the steerable sleeve soft tip.The clip appears to be in a fully closed position (< 10°) and is positioned in an abnormal manner such that the clip is rotated ~90° about the dc l-lock shaft.While the clip is positioned orthogonally to the l-lock shaft, as described, it appears the clip is attached / contacting the l-lock shaft in the image.This indicates that the coupler has successfully been detached from the clip and retracted into the dc.During normal use, the clip maintains attachment to the l-lock shaft via the coupler, which is located within the l-lock shaft, pushing the l-lock tines into the clip connector windows.During deployment maneuvers per the instructions for use, the user rotates the actuator knob counterclockwise, effectively unthreading the coupler from the threaded stud of the clip.The user then retracts the actuator knob which retracts the coupler from within the l-lock tines, allowing the tines to bend inward and disengaging with the clip connector.The general state of the distal components indicates a full detachment of the clip connector from the l-lock tines.There is no evidence of clip or l-lock damage based on a visual assessment of the image with the naked eye.Per the ifu, the user then retracts the gripper levers.During normal use, this action retracts the gripper line distal trumpets from the l-lock shaft, allowing the gripper lines to be pulled through gripper sutures of the clip; this step is the final mechanical separation between the dc and the clip.Based on the position of the clip relative to the l-lock shaft in the image provided, the clip is likely still connected to the l-lock shaft via the gripper lines, thus holding the clip orthogonally against the l-lock shaft.This aligns with the reported incident details that "during deployment, due to tension on the catheter, the gripper line did not come out.As part of the troubleshooting steps, the gripper lines were accessed, and they immediately snapped back into the device".The provided image confirms the reported inability to detach the gripper lines from the clip during deployment.The reported unintended clip movement (rotation), tension on the catheter, and subsequent clip entanglement / interaction with the anatomy cannot be commented on or assessed as the image provided does not capture these instances.There are no other observations based on the image provided.

• 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: 18768254
• MDR Text Key: 336119090
• Report Number: 2135147-2024-00844
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: (01)05415067037435(17)240911(10)30912A1043
• 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: 04/16/2024

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-NTW
• Device Lot Number: 30912A1043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male