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

Catalog Number CDS0706-XT

Device Problems Entrapment of Device (1212); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problems Mitral Valve Stenosis (1965); Foreign Body In Patient (2687)

Event Date 01/31/2024

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 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3-4+, a restricted posterior leaflet, and a mean pressure gradient of 3mmhg.It was noted imaging was challenging throughout the procedure.Two clips were successfully implanted.To further reduce mr, a third xt clip was inserted and advanced under the mitral valve.However, the clip became caught in the chordae and was unable to be removed.Standard troubleshooting maneuvers were performed, but the issue was unable to be resolved.Therefore, the clip was attempted to be deployed.However, after the lock line and pin were pulled, the groove could not be exposed.There was difficulty detaching the mandrel from the clip.It was noted the grippers appeared to still be attached to the device.Troubleshooting was performed; the gripper lines were pulled out manually.The clip was then able to detach from clip delivery system (cds) and was deployed only on the posterior leaflet.Mr reduced slightly to a grade of 3-4, and mitral stenosis was noted with an increase in pressure gradient of 7mmhg.There was no clinically significant delay in the procedure.

Manufacturer Narrative

In this case, the difficult or delayed activation-clip deployment could not be replicated in a testing environment due to the condition of the returned device (clip was deployed/implanted and therefore was not returned).The reported image resolution poor and entrapment of device-clip caught on chordae could not be replicated in a testing environment as it was related to patient or procedural / operational circumstances.The reported physical resistance / sticking of the gripper line could not be replicated in a testing environment due to the device returned condition (gripper lines were removed from cds).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and based on the information provided and the image review, the reported difficult or delayed activation (difficult to deploy the clip) and difficulty removing the gripper lines appear to be related to the clip becoming entangled in chordae (entrapment of device).A cause for how the clip became caught in anatomy, however, could not be determined.Image resolution poor is related to patient and procedural conditions as imaging was reported to be challenging throughout the procedure due to shadowing.Foreign body in patient appear to be related the procedural conditions associated with the clip becoming caught in anatomy.A cause for the mitral stenosis, however, cannot be determined.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.Imaging review: a total of four (4) fluoroscopic videos were provided, with two of the videos being duplicates.Video "(b)(6) video 1" and "psvpostgripperremovel" are the same video taken during deployment troubleshooting of the third clip reported for difficult deployment (activation).In the video, the first and second implanted clip (no reported issue) are the top and middle clips, with the third implanted clip (reported device) located at the bottom.The third clip appears to be in a fully closed position (~10°) and is detached from the l-lock shaft tines which are visible on the left side of the video.The distal actuator assembly can be seen exiting the l-lock shaft with ~1 cm of the mandrel exposed, and the coupler is visible in between the clip arms.Reference figure 1 which provides a labeled snapshot from video 1.Based on the dimensional lengths of the threaded stud of the clip and coupler, it is likely that the coupler is still attached to the threaded stud in the video.The user is able to actuate (open / close) and deploy (detach) the clip via the internal actuator assembly, which is comprised of two components: the mandrel component which runs the entire length of the cds, and the coupler component which is welded at the end of the mandrel.During normal use, prior to deployment, the coupler is located in between the l-lock tines providing an outward force, pushing the tines into the connector windows of the clip; this creates a mechanical attachment between the clip and the l-lock shaft of the delivery catheter (dc).During deployment per the ifu, the coupler is unthreaded from the threaded stud of the clip (rotate actuator knob ~8 times) and retracted ~1 cm into the dc shaft by the user.This allows the l-lock tines to rest inwards to their natural state and disconnect from the connector windows, inducing mechanical separation as intended.Based on video 1, the clip is confirmed detached from the l-lock shaft tines; however, the coupler appears to be attached to the threaded stud.Mechanically, for this scenario to occur the actuator assembly would need to be translated distally an excessive amount such that the coupler, while attached to the threaded stud, is pushed outwards from within the l-lock tines.As the mandrel component is much thinner than the coupler there is sufficient space for l-lock tines to relax inward to their natural state, detaching from the clip connector.The mechanical scenario described coincides with the reported incident details that "after the lock line and [release] pin were pulled, the [release pin] groove could not be exposed.There was difficulty detaching the mandrel from the clip".This indicates that the actuator assembly was being pulled distally such that the release pin groove of the crimping cam was pulled further into the dc handle.The crimping cam is crimped onto the proximal end of the actuator assembly.Functionally, the release pin component serves as a mechanical connection between the arm positioner and internal actuator assembly (the clip is attached distally to the actuator assembly via the coupler).During normal use prior to removal, the release pin allows rotational movement of the arm positioner by the user to be translated into linear movement of the actuator assembly via the crimping cam.When the arm positioner is rotated in the open direction, the actuator assembly is translated distally which applies a compressive force at the clip to essentially push the clip arms open.During deployment, per the instructions for use, the arm positioner is place in neutral prior to removing the release pin; this action is intended to alleviate any residual force on the actuator assembly/clip.When the release pin is removed, the mechanical connection between the arm positioner and actuator assembly/clip is removed.If the release pin groove was unable to be exposed after the release pin was removed, this indicates the actuator assembly was likely pulled distally at the clip due to the reported clip entanglement in the chordae.Subsequent deployment troubleshooting maneuvers likely retracted the dc over the actuator assembly, pushing the clip and coupler away from the l-lock shaft as seen in video 1.With the mandrel still within the l-lock shaft, this could result in difficulty retracting the gripper lines, as reported.Video "(b)(6) video 2" and video "psv1312430postgripperremoval" are the same video taken post deployment (mechanical separation) of the reported clip.In the video, the clip is fully detached from the coupler and the distal actuator assembly (mandrel + coupler) is no longer visible indicating the user was able to successfully detach the coupler from the threaded stud and retract into the dc to deploy the clip.This aligns with the reported incident details that "troubleshooting was performed; the gripper lines were pulled out manually.The clip was then able to detach from clip delivery system (cds) and was deployed only on the posterior leaflet".There is no evidence of damage to the l-lock shaft or clip in video 2.Lastly, it is noted that the first two clips (no reported issue) are positioned in similar orientation typically observed in side-by-side implanted clips.The third clip (reported device) is rotated ~90° about the longitudinal axis of the clip, as compared to the first two clips.This suggests challenging anatomy, such as thick leaflets, and / or chordae grasped within the clip arms, resulting in increased tension on the clip and aligns with the reported incident details.There are no other observations based on the videos 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: 18747310
• MDR Text Key: 335871199
• Report Number: 2135147-2024-00778
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)240920(10)30918A1022
• 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: 04/26/2024

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-XT
• Device Lot Number: 30918A1022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2023
• 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: IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 68 KG