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

Model Number	CDS0706-XT
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, mitraclip was advanced into left atrium.A clot was observed at the end of the clip.The clip was retracted into the steerable guide catheter (sgc) for removal of clot.Upon removal, the clip damaged the hemostatic valve of the sgc.The clip and sgc were replaced with another devices to complete the procedure.The mr was reduced to grade 1+ post procedure.There was no clinically significant delay.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All information was investigated and based on the information provided, a cause for the reported device damaged by another device (caused damage) and thrombosis/thrombus cannot be determined.Thrombus is a known possible complication associated with mitraclip procedures.Serious injury/illness/impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Common Device Name: 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: 23295392
• Report Number: 2135147-2025-05849
• Device Sequence Number: 4863561
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)260305(10)50306R1087
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2026
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 50306R1087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown