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

Catalog Number CDS0705-XTW

Device Problems Difficult or Delayed Positioning (1157); Retraction Problem (1536); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

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

Event Date 12/23/2022

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 is filed to report retraction problem, clip deployment difficulty, and difficulty positioning.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.When steering, + knob was used due to aorta hugger.A knob was used because the height was not enough.Still, the physician could not fully pull the dc handle during grasping, so they grasped both leaflets under straddled.Since mr was reduced, it was decided to deploy the clip.During deployment steps, the physician pulled the actuator knob, raised the gripper lever, and pulled the dc handle, but the clip and shaft did not disengage.The physician was carefully pushing and pulling the dc handle, and the clip was able to be deployed.According to the doctor's opinion, the cause was that the steerable guide catheter (sgc) and clip delivery system (cds) were under straddled.A small amount of clip-through jet was confirmed, likely due to the original pathology of pseudo prolapse.Mr was reduced to grade 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

N/a.

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 other complaints reported from this lot.Based on the information reviewed, the reported difficult or delayed positioning with anatomy and the reported difficult or delayed activation associated with the clip deployment appeared to be related to procedural circumstance (not enough height and the sgc and cds were not coaxial).A cause for the reported retraction problem of the dc handle could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.H6 medical device problem code 2920 removed.

• 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: 16173730
• MDR Text Key: 307829829
• Report Number: 2135147-2023-00194
• 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
• Report Date: 03/15/2023

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: 08/03/2023
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 20803R1086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 62 KG