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

Catalog Number CDS0706-XTW

Device Problems Premature Activation (1484); Off-Label Use (1494); Difficult to Remove (1528); Difficult to Open or Close (2921)

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

Event Date 10/05/2023

Event Type  malfunction  

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 similar complaints reported from this lot.Based on available information, a cause of the reported difficult to open or close (clip close - inability) could not be determined.The reported difficult to remove (cds/sgc) appears to be due to user retraction technique.The reported premature activation of the clip was a cascading effect of the reported difficult to remove (cds/sgc).The reported off-label use is due to the user using mitraclip device on the tricuspid valve.It should be noted the mitraclip instruction for use states: "the mitraclip g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation due to primary abnormality of the mitral apparatus in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team." there is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: 1494 - off-label issue - indication for usena.

Event Description

It was reported that a mitraclip procedure was performed to treat the tricuspid valve with functional tricuspid regurgitation (tr) with grade 3.A mitraclip xtw was advanced to the tricuspid valve, but the clip would not open, and each subsequent attempt was difficult.Troubleshooting was performed but was not successful.A decision was made to remove the clip.While retracting the clip into the steerable guide catheter, the clip became stuck on the tip of the guide.The clip system was pulled hard, and the clip detached from the end of the shaft.The steerable guide catheter (sgc) and the clip delivery system (cds) were removed together with the clip still attached to the lock line.The procedure was completed with no clips implanted on the tricuspid valve.The tr remained at grade 3.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18030170
• MDR Text Key: 326858212
• Report Number: 2135147-2023-04753
• 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
• Report Date: 10/30/2023

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: 04/01/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30403A1078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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 Age: 88 YR
• Patient Sex: Male