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

Model Number	CDS0706-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	11/20/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, an enlarged atrium, dilated annulus, and a 6mm2 mitral valve area on a patient with a medical history of heart failure (hf), renal disease, coronary artery disease (cad).Two mitraclip xtw clips were inserted and deployed on the mitral valve without issues.A third clip, a mitraclip xt (50304a1041), was then inserted and deployed on the mitral valve.However, post deployment, imaging revealed chordal rupture and that the clip had detached from the posterior mitral leaflet (pml) and remained attached to the anterior mitral leaflet (aml) (single leaflet device attachment/slda).To stabilize the clip, a fourth clip, a mitraclip ntw (50313a2091), was inserted, and grasping was performed.However, difficulties grasping and capturing the leaflets occurred.Therefore, the clip was removed from the patient.The procedure was discontinued, and the mr was reduced to a grade of 3+.On (b)(6), 2025, the patient died due to heart failure (hf) and severe mr.It was noted that the clips were stable on the leaflets.
Additional Manufacturer Narrative
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 did not indicate a lot-specific quality issue.Based on available information, a cause for the reported incomplete coaptation- single leaflet device attachment (slda) could not be determined.The reported chordal rupture is likely a cascading effect of the slda.The cause of the reported recurrent mitral valve insufficiency/ regurgitation (mr) could not be determined.Per the medical review, the cause of the reported death appears primarily due to underlying heart failure, with possible worsening due to the procedure.Mr, heart failure, tissue injury, and death, are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances as an additional clip (same procedure) was attempted to be implanted.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, an enlarged atrium, dilated annulus, and a 6cm2 mitral valve area on a patient with a medical history of heart failure (hf), renal disease, coronary artery disease (cad).Two mitraclip xtw clips were inserted and deployed on the mitral valve without issues.A third clip, a mitraclip xt (50304a1041), was then inserted and deployed on the mitral valve.However, post deployment, imaging revealed chordal rupture and that the clip had detached from the posterior mitral leaflet (pml) and remained attached to the anterior mitral leaflet (aml) (single leaflet device attachment/slda).To stabilize the clip, a fourth clip, a mitraclip ntw (50313a2091), was inserted, and grasping was performed.However, difficulties grasping and capturing the leaflets occurred.Therefore, the clip was removed from the patient.The procedure was discontinued, and the mr was reduced to a grade of 3+.On (b)(6) 2025, the patient died due to heart failure (hf) and severe mr.It was noted that the clips were stable on the leaflets.Subsequent to the previously filed report, additional information was received that the patient died on (b)(6) 2025.

• 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: 23811897
• Report Number: 2135147-2025-07395
• Device Sequence Number: 7707273
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)260303(10)50304A1041
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/19/2026

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: 03/03/2026
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 50304A1041
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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: STEERABLE GUIDE CATHETER, 2 IMPLANTED CLIPS.
• Outcome Attributed to Adverse Event: Death; Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 92 KG