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

Catalog Number CDS0705-XTW

Device Problems Material Deformation (2976); Unintended Movement (3026); Migration (4003); Physical Resistance/Sticking (4012)

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

Event Date 11/08/2023

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 patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During lock lever cap and o-ring removal of the mitraclip xtw, the lock line became tangled and a knot was observed on one end.The knot was cut, and there were no other knots or fraying observed.The deployment sequence continued.The clip was closed at a 20 degree angle.After deployment, the clip opened slightly to a 30 degree angle, with no impact to the reduced mr achieved.About 30 minutes later, the clip opened further.The clip had opened to a 45 degree angle.Mobility of the posterior leaflet and clip increased, and mr was grade 1-2.After another 30 minutes, an additional clip was considered after observing leaflet insertion.There was no increase in mobility of the posterior leaflet, mr grade, and considering procedural risk of additional clips, it was decided to observe the patient's condition instead.There were no adverse patient sequelae or clinically significant delay.No additional information was provided.

Manufacturer Narrative

A correction report was submitted to include investigation codes in h6.

Manufacturer Narrative

In this case, the reported knot on the lock line, inability to remove the lock line, clip open while locked (cowl) & migration (partial clip movement) could not be replicated.Additionally, it was observed that actuator coupler was corroded, and l-lock tabs were scratched.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, the reported inability to remove the locked is due to user technique.The knot on the lock line was a cascading effect of the reported inability to remove the lock line.The cause of the reported cowl cannot be determined.It is possible that procedural conditions (clip arm relaxation) or patient anatomy (increased posterior leaflet movement) contributed to the reported issues.The reported migration (partial clip movement) appears to be due to a combination cowl and patient anatomy (increased posterior leaflet movement).The reported corrosion on the actuator coupler appears to be a result of post procedural exposure to saline and scratched l-lock tabs appears to be a result of post procedural handling of the device.The reported medical intervention was a result of case-specific circumstances as an additional clip was implanted to treat the reported cowl.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Imaging review: two (2) echocardiographic still images of the reported clip were provided.Both images capture an lvot view (right) with intercommissural x-plane (left).The lvot view captures the anterior-posterior cross-section of the valve (short axis); the echo view bisects a clip grasped on the valve (cross-section through the clip arm plane) providing a general view of the clip arm angle.The first image provided was reportedly taken "after clip placement" in which the clip appears fully deployed with no delivery catheter (dc) in view indicating the image taken post deployment (mechanical separation); the clip arm angle appears to be ~30°.It was reported that "the clip was closed at a 20 degree angle [pre-deployment].After deployment, the clip opened slightly to a 30 degree angle, with no impact to the reduced mr achieved.About 30 minutes later, the clip opened further.The clip had opened to a 45 degree angle".Presumably, the first image was likely taken within the 0 min.- 30 min.Post deployment time frame when the "the clip opened slightly to a 30 degree angle".The second image provided was reportedly taken "after the clip is opened" in which the deployed clip appears to have a clip arm angle of ~45°; presumably, the image was taken ~ 30 mins.Post deployment when it was observed that "about 30 minutes later, the clip opened further.The clip had opened to a 45 degree angle".While the angles stated in this evaluation are estimations based on visual assessment with the naked eye and are not confirmed, it is apparent that the clip arms are opened to a wider angle in the second image, as compared to the first image, indicating a potential clip arm angle change of ~10°.No pre-deployment cine of the reported clip was provided; as such, no assessment or comment can be made regarding the pre-deployment state of the clip (clip arm angle prior to dc detachment), if and/or by how much the clip opened prior to mechanical separation.However, the images provided appear to align with the reported incident details that a post deployment cowl was observed ~ 30 mins.Post deployment.

• 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: 18221845
• MDR Text Key: 329167781
• Report Number: 2135147-2023-05227
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/18/2024

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 Expiration Date: 05/29/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30530R1045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/18/2024; 01/18/2024
• Supplement Dates FDA Received: 01/18/2024; 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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: 81 YR
• Patient Sex: Female