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

Model Number	CDS0706-XT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ functional mitral regurgitation (mr) and restricted leaflets for a mitraclip procedure.During preparation of the steerable guide catheter (sgc), the flush port of dilator broke while tightening the stopcock to the flush port.The sgc was replaced with another device to complete the procedure.During the procedure, a mitraclip xtw was inserted into the anatomy but removed after a jet was observed lateral to the anterior and posterior leaflet at anterior and posterior leaflet 2 (a2p2).A mitraclip xt was then inserted but removed due to a flail leaflet caused by multiple grasping attempts.Finally, a mitraclip xtw was successfully deployed at the lateral a2p2 segment.The mr was reduced to grade 2+ post procedure.There was no clinically significant delay.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional 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 similar complaints reported from this lot.The investigation determined the reported positioning failure of inability to grasp appears to be related to patient morphology/pathology.The reported patient effect of tissue injury was due to due to the indentation and thin leaflet.Tissue injury is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no additional intervention was performed for the tissue injury.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ functional mitral regurgitation (mr) and restricted leaflets for a mitraclip procedure.During preparation of the steerable guide catheter (sgc), the flush port of dilator broke while tightening the stopcock to the flush port.The sgc was replaced with another device to complete the procedure.During the procedure, a mitraclip xtw was inserted into the anatomy but removed after a jet was observed lateral to the anterior and posterior leaflet 2 (a2p2).A mitraclip xt was then inserted but removed due to a flail leaflet caused by multiple grasping attempts.Finally, a mitraclip xtw was successfully deployed at the lateral a2p2 segment.The mr was reduced to grade 2+ post procedure.There was no clinically significant delay.

• 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 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: 23729102
• Report Number: 2135147-2025-07179
• Device Sequence Number: 10631427
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)260123(10)50124A1124
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/16/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2026
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 50124A1124
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MITRACLIP.; STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 120 KG