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

Catalog Number CDS0706-XTW

Device Problems Break (1069); Difficult to Open or Close (2921)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.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 on (b)(6) 2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+ and bilateral leaflet restriction.An xtw clip was inserted and deployed on the mitral valve.To further reduce mr, an additional xtw (31016a1031) was inserted.However, while grasping, it was observed that the posterior gripper was not functioning as intended.Troubleshooting was performed, but the issue was unable to be resolved.At this point, the lock lever could not be moved into the lock position and broke in the unlock position.The clip was removed safely from the patient.An ntw clip (30510r1109) was inserted and advanced to the left ventricle (lv).However, while in the lv, the clip became caught in chordae and the leaflet.Troubleshooting was performed and the clip was successfully removed from the chordae.However, it was observed that an anterior leaflet perforation occurred.It was noted that difficulties visualizing the clip occurred.The ntw was removed from the patient.To close the leaflet perforation, an xtw clip was implanted.However, mr remained at a grade of 4+.No additional clips were implanted, and the procedure was discontinued.On (b)(6) 2024, a transthoracic echocardiogram (tte) was performed and revealed mr had decreased to a grade of 2-3.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated and the reported gripper actuation issue and lock lever stuck in unlock position were not confirmed via returned device 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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported gripper actuation issue and lock lever stuck in unlock position.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 18933145
• MDR Text Key: 338560118
• Report Number: 2135147-2024-01235
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31016A1031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2023
• 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: 1 IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG