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

Catalog Number CDS0705-XTW

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

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

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4, thick leaflets, and some focal calcification.One clip was successfully implanted, reducing mr to a grade of 3.To further reduce mr, an xtw clip was inserted, but while positioning in the left atrium (la), the posterior gripper would not lower.Therefore, the decision was made to not use the clip.However, while attempting to remove the clip, it became caught on the tip of the steerable guide catheter (sgc).Troubleshooting was performed, but the devices were unable to be separated.Therefore, both devices were retracted together.When retracting from the right atrium (ra) into the femoral vein, the clip detached from the mandrel.It was noted the clip remained attached to the lock line.Minor surgery was needed to remove the mitraclip devices.The procedure was discontinued, and mr was reduced to a grade of 3.The steerable guide catheter (sgc) was examined after removal of the device and damage was noted on the soft tip.An indent at the tip of the guide where the clip had been stuck was noticed.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: medical device problem code: 2017 - failure to follow steps/instructions.In this case, during the returned device analysis the reported gripper actuation issue, premature activation during procedure could not be replicated in a testing environment due to the returned condition of the device (clip was detached).The reported difficulty to remove the clip delivery system (cds) from the steerable guide catheter (sgc), clip¿s interaction with the anatomy and instruction for use (ifu) deviation could not be replicated in a testing environment as it was related to patient/procedural conditions or operational circumstances.Additionally, it was observed that the dc shaft was deformed & cracked, actuator coupler was broken, harness was deformed, frictional elements were bent, gripper cover was torn & frayed, and connector was 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 and returned device analysis, the clip¿s interaction with the anatomy appears to be due to the user technique.The cause of the reported gripper actuation issue cannot be determined.The cause of the reported ifu deviation was due to the user not returning the arm positioner to neutral position before retraction into the guide and not straightening the guide prior to retraction.The difficulty to remove the cds from the sgc appears to be a cascading effect of the reported ifu deviation.The reported premature activation, the observed deformed & cracked dc shaft, broken actuator coupler, deformed harness, bent frictional elements, torn & frayed gripper cover, and scratched connector are cascading effects of the reported difficult to remove cds from the sgc.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previously filed report, additional information was received: it was noted that there was some very brief, minor interaction with the leaflet tissue.

• 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: 18030574
• MDR Text Key: 326862466
• Report Number: 2135147-2023-04766
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/17/2024

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: 06/19/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30621R1098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male