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

Model Number CDS0706-XTW

Device Problems Material Protrusion/Extrusion (2979); Unintended Movement (3026)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This will be filed to report the clip opening while locked and material protrusion.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with rotated heart.When deploying the clip, there was a lot of tension on the system and the mandrel jumped forward and made contact with the clip.The clip opened approximately to 30-35 degrees.After deployment, mr increased from grade 1-2 to 2-3.Another clip was implanted with no reported issue; however, mr was not reduced.No additional information was provided.

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 did not indicate a lot-specific quality issue.Based on available information and without the device to analyze, a cause of the reported unintended movement (clip open while locked) and material protrusion/ extrusion (actuator mandrel, distal) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Cine review: all four still images capture the same instance in which a single, fully deployed clip can be visualized; there is no cds in view indicating the images were taken post deployment of the first clip (reported device) and after cds removal, prior to insertion of the second cds.Based on the images, the clip arm angle appears to be ~20° - 30°; this is an estimation based on visual assessment with the naked eye and cannot be confirmed.No pre-deployment cine of the reported clip was provided; as such, no assessment or comment regarding the pre-deployment state of the clip (clip arm angle prior to dc detachment), when and/or by how much the clip opened, can be made.There are no additional observations based on the fluoro images.Echocardiography cine ¿ fifty-six (56) videos were taken initial assessment, transeptal puncture, and sgc insertion into the left atrium.¿ nineteen (19) videos were taken during usage of the reported cds.The videos show a normal cadence of use in accordance with instructions for use, with no issues or abnormalities observed.The videos were further assessed to identify videos capturing the clip arms grasped and fully closed onto the leaflets pre deployment and post deployment to compare the arm angle and assess for potential dc shaft movement/contact with the clip.Video #75 (titled "img06755845") provides an lvot view with x-plane view of the cds with the clip fully closed onto the leaflets.The lvot view (or similar x-plane view) captures the anterior-posterior cross-section of the valve (short axis); as such, an lvot view will potentially provide a view of the clip arm angle.The video was taken during active separation of the clip from the dc shaft in which the dc shaft can be seen retracting away from the clip, confirming detachment, in both the lvot view and the x-plane view.As the video progresses, the dc shaft seemingly appears fully extended through the valve plane on the posterior side of the clip in the lvot view.However, in the x-plane view there is no movement/advancement of the dc shaft; the steerable sleeve, radiopaque (ro) tip ring and l-lock shaft of the dc can be visualized and do not show any movement toward the valve or clip; there is notable shadowing extending off the l-lock shaft that extends down to the valve plane (see provided figure 1).This shadowing is also seen in the lvot view and ca be easily mistaken as the dc shaft itself.Furthermore, in the subsequent video the radiopaque tip ring of the dc shaft can be visualized, located centrally in the la, with significant shadowing along the l-lock shaft, artificially lengthening the shaft.This gives the appearance/illusion that the shaft is fully extended down to the valve plane (see provided figure 2).Based on the assessment of these two key videos, the reported movement of the dc shaft (referred to as "mandrel" in incident details) and contact with the deployed clip cannot be confirmed.Rather, shadowing from the cds gave the appearance of dc shaft movement/artificial lengthening towards the valve/clip.Lastly, there does not appear to be a significant change in the clip arm angle pre and post detachment / separation of the clip from the dc shaft based on a visual assessment with the naked eye.¿ the remaining one hundred (100) videos were taken post deployment of the first clip (reported device) and usage of the second cds which showed a normal cadence of use in accordance with instructions for use, with no issues or abnormalities observed.".

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 15818226
• MDR Text Key: 307834655
• Report Number: 2135147-2022-02088
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 02/08/2023

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 Expiration Date: 07/21/2023
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 20721R1044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 78 YR
• Patient Sex: Female