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

Catalog Number CDS0706-NT

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)

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

Event Date 03/07/2024

Event Type  malfunction  

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.

Event Description

It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4, a calcified annulus, calcified chordae, and a short, thin, and restricted posterior leaflet.It was noted imaging was difficult throughout the procedure.One ntw clip was inserted and successfully implanted.To further reduce mr, a second nt clip was inserted and advanced to the mitral valve.However, the clip became caught in the anatomy multiple times.Troubleshooting maneuvers were performed, and the clip was able to be removed.However, while grasping and simultaneously actuating both grippers, the posterior gripper would not lower or raise.Troubleshooting was performed, including re-locking the clip and actuating the grippers, but the issue was unable to be resolved.Therefore, the clip was removed from the anatomy and replaced.While outside the anatomy, the gripper line was observed to be severed and not attached to the gripper.The procedure was continued, and a new ntw clip was successfully implanted, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

The product was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and while the reported single gripper actuation issue appears to be related to the reported gripper line break, a cause for how the gripper line broke could not be determined.Additionally, a cause for difficult or delayed positioning associated with the clip interacting with the anatomy cannot be determined.Image resolution poor is related to patient and procedural conditions as imaging was reported to be challenging due to patient anatomy.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 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: 19013863
• MDR Text Key: 339081984
• Report Number: 2135147-2024-01424
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)240313(10)30315R1021
• 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,Followup
• Report Date: 05/07/2024

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: 03/13/2024
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 30315R1021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2023
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Weight: 46 KG