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

Catalog Number CDS0702-XTW

Device Problems Premature Activation (1484); Difficult to Open or Close (2921)

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

Event Date 12/26/2023

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.The xtw clip could not open during the initial attempt to open in the left atrium.Troubleshooting was performed, and the operator cannot recall if after unlocking the clip further past the blue line, if the arm positioner was rotated in the close direction before the open.The clip could not opened and was attempted to retract into the steerable guide catheter (sgc).As the clip was retracted, the clip prematurely activated and detached from the clip delivery system (cds).The clip was able to be removed, as it was still attached to the lock line and pulled back into the sgc.A total of 3 clips were implanted and the mr was reduced to grade 1.There were no adverse patient effects.There was a 45 minute delay, but there was no patient harm due to the delay.

Event Description

It was reported that during removal of the clip delivery system (cds) into the steerable guide catheter (sgc), the clip was met with resistance at the soft tip.The physician did not note any damage to the soft tip.The sgc was received on 12jan2024, and soft tip damage was noted.Additionally, the release pin had been removed during the procedure in order to fully deploy the clip to catch it with a snare to remove the device.The system was removed as a unit (sgc with the cds).

Manufacturer Narrative

All available information was investigated, and the reported difficult to open or close (clip open inability - anatomy), premature activation (n/a), and difficult to remove could not be replicated in a testing environment.The release pin was not returned at the crimping cam.The harness was observed deformed (bent).The lock line was observed to be frayed.The l-lock tabs were observed to be scratched.Additionally, upon destructive testing, the binding plate was found to be cracked, and the actuator coupler was corroded.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.Based on available information, a cause of the reported difficult to open or close (clip open inability - anatomy), associated with the clip¿s inability to open in the left atrium, could not be determined.The reported premature activation, associated with the clip detachment from the delivery system during clip retraction, was due to procedural circumstances (i.E., forced retraction into the steerable guide against significant amount of resistance due to clip interaction with soft tip).The reported difficult to remove (cds/ sgc), associated with the clip interacting with sgc soft tip, appears to be due to user technique of removing the cds.The observed material separation (clip) was a result of the premature activation.The observed missing release pin was due to procedural handling as the user intentionally removed the release pin.The observed harness deformation and lock line fray were due to the removal attempt with only the lock line attached to the clip.The observed scratched l-lock tabs was a cascading effect of the premature activation as the l-lock tabs were forced out of the connector windows.A cause of the binding plate cracking could not be determined.The observed corrosion was due to post procedural storage condition.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 18510475
• MDR Text Key: 333475337
• Report Number: 2135147-2024-00229
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/18/2024

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 Catalogue Number: CDS0702-XTW
• Device Lot Number: 30914R2012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2023
• 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