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

Catalog Number CDS0702-XT

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a flail.One clip was successfully implanted.To further reduce mr, another clip was inserted.However, it was observed that both grippers were not lowering when moving the gripper levers.Due to a small orifice between the first clip and commissural wall, the physician was unable to retract the clip into the left atrium (la).Therefore, the clip was deployed on both leaflets, reducing mr to a grade of 1-2.No clinically significant delay in the procedure.

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 other complaints reported from this lot.Based on the available information and without the return device to analyze, the cause of the reported inability to move the gripper cannot be determined.The reported medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Manufacturer Narrative

In this case, the reported difficult to open or close (gipper actuation - both) could not be replicated in a testing environment due to the returned condition of the cds (clip was deployed and not returned).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 other complaints reported from this lot.Based on the available information and returned device to analysis, the cause of the reported inability to move the gripper cannot be determined.The reported medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: code 4117 was removed.

• 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: 18547543
• MDR Text Key: 333286422
• Report Number: 2135147-2024-00301
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/14/2024

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 Expiration Date: 06/03/2024
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 30605R1040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention