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

Catalog Number CDS0706-XT

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921); Unintended Movement (3026)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.There were no challenges with anatomy.It was noted that the delivery catheter (dc) handle was difficult to retract.Resistance was noted during the motion of pulling back the dc handle, while steering down to position above the valve.In the left atrium during gripper orientation, there was more resistance than normal while actuating both grippers.The grippers were able to actuate the full range (lower and raise).They procedure proceeded.After detachment from the clip delivery system (cds), the clip opened while locked.The clip was fully closed to a v-shape, and opened more than 7 degrees from closed.The clip remained stable and did not require and additional clip for stabilization.A second clip was initially planned and was implanted to further reduce the mr.The mr was reduced to grade 1.There were no adverse patient effects or clinically significant delay.

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.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 was unable to determine a cause for the reported gripper actuation issue and retraction problem of the handle.The reported clip open while locked (clip opened approximately 7 degrees from closed) appears to be related to settling of the lock mechanism.There is no indication of a product issue with respect to manufacture, design, or labeling.Imaging review: two (2) fluoroscopic still images of the reported device were provided.The first image (titled "3.6.24 not deployed") shows the delivery catheter (dc) shaft extended with the clip attached to the l-lock shaft indicating the image was taken prior to deployment (mechanical separation).The clip arm angle appears to be ~25° - 30°; it is unclear at which specific procedural step the image was taken.There were no reported issues regarding clip opening during efaa checks or lock line removal prior to deployment (mechanical separation).Follow up was sent to the reporting abbott employee regarding the clip angle before opening was observed and it was stated that the clip was "fully closed, v-shaped".To this end, it is presumed that the pre-deployment clip arm angle is ~25° - 30° as seen in the first image.The second image (titled "3.6.24") shows the reported clip fully deployed (separated) with the dc shaft fully retracted against the steerable sleeve.The post deployment clip arm angle appears to be ~30° - 35°.The angles stated in this evaluation are estimations based on visual assessment with the naked eye and are not confirmed.When comparing the clip arm angle in the pre and post deployment images provided, it is possible there was a slight arm angle change of ~5° - 10°; however, this is within the range of normal clip lock settling.Assuming the clip arm angle was ~25° - 30°, as captured in the first image take pre-deployment, the post deployment state of the clip in the second image does not present with a significant arm angle change typically associated with a cowl event.Furthermore, the angle at which the clip is oriented in the first image (pre-deployment), with the l-lock shaft located in between the clip arms, can obscure the view of the clip arm angle.When the clip is deployed and the l-lock shaft is retracted from within the clip arms, the space between the clip arms becomes clearer and can give the perception of clip arm opening.Based on visual evaluation of the clip arm angle in the images provided, the clip arm angle possibly changed = 10° post deployment which is within the expected range of normal behavior associated with the clip lock mechanism settling and not necessarily indicative of a cowl event.There are no additional observations based on the images 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: 18990091
• MDR Text Key: 338768732
• Report Number: 2135147-2024-01370
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)240808(10)30803A1050
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 30803A1050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2023
• 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 Age: 87 YR
• Patient Sex: Male
• Patient Weight: 73 KG