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

Catalog Number CDS0702-XTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/09/2024

Event Type  Injury  

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.Based on the available information the cause of the reported thrombus cannot be determined.The reported thrombus as listed in the mitraclip system instructions for use (ifu) is a known possible complication associated with mitraclip procedures.The reported medication is the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported the procedure was performed to treat functional mitral regurgitation (mr) with a grade of 2-3.An xtw clip was inserted and grasping was performed, but a small floating structure was observed at the clip/delivery catheter shaft despite heparin injection and sufficient activated clotting time (act).Act maintained above 250 seconds throughout the procedure.Therefore, the physician decided to administer an additional heparin bolus.It was noted the structure was no longer detected.The clip was successfully implanted, reducing mr to a grade of <1.There was no clinically significant delay in the procedure.

• 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: 18565609
• MDR Text Key: 333505603
• Report Number: 2135147-2024-00336
• 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
• Report Date: 01/23/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30807R1056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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 Outcome(s): Required Intervention