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

Catalog Number CDS0702-XTW

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

All available information was investigated and the reported inability to open the clip and retraction problem of the clip introducer were not confirmed via returned device analysis.However, it was observed that the clip introducer was difficult to remove as it was observed that the clip introducer material was caught by the clip arms.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.The investigation was unable to determine a cause for the reported inability to open the clip.The reported retraction problem/observed difficult to remove the clip introducer appears to be due to the user technique of retracting the device.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.The first clip, an xtw clip was aseptically prepared and tested as per instructions for use (ifu).All functionality was good during testing.However, during the first attempt to establish grasping arm angle within the left atrium (la), the clip failed to open.Several troubleshooting attempts were carried out, but clip could not open.The clip delivery system (cds) was therefore removed.It was noted to be difficult retracting the clip into the clip introducer.Once removed, further tests were performed to try and establish fault.It took several attempts before clip eventually opened.Two new xtw clips and one nt clip were subsequently implanted with no issues.There was no adverse effect to patient or unnecessary delay of procedure.No additional information was provided.

• 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: 18309767
• MDR Text Key: 330274726
• Report Number: 2135147-2023-05431
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/12/2023

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: 03/27/2024
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30329R1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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