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

Model Number	CDS0706-XTW
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat grade 4 mitral regurgitation (mr) in an 81-year-old patient with thin, wispy leaflets, mitral annular calcification (mac), and a challenging transseptal puncture that resulted in limited steering capability.A mitraclip xtw was inserted.However, it was noted that there was limited room to steer the device due to the transseptal puncture.Despite this, the first clip was successfully deployed on the mitral valve.Following deployment, the physician provided a visual observation, though it was not clear whether the observation was related to normal post-deployment settling or any other device-related finding.It was noted that the clip angle before opening was 20 degrees.The clip angle after opening was undetermined but it was noted that it was over 20 degrees.However, it was reported that the clip remained stable on the leaflets, and the outcome was deemed positive, with no adverse patient consequences.After the implant of the initial clip, there was reduction in mitral regurgitation.The physician thought the clip had opened but was not sure if it was clip opened while locked.It was not confirmed.To further reduce mr, two additional mitraclip xt devices were implanted on the mitral valve, resulting in an mr grade of 2¿3.There were no adverse patient effects and no clinically significant procedural delays.The patient was reported to have been discharged.
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 identified no similar complaints reported from this lot.The investigation determined the reported difficult or delayed positioning appears to be related to patient and procedural conditions.However, a cause for the reported unintended movement associated with clip opening while locked could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat grade 4 mitral regurgitation (mr) in an 81-year-old patient with thin, wispy leaflets, mitral annular calcification (mac), and a challenging transseptal puncture that resulted in limited steering capability.A mitraclip xtw was inserted.However, it was noted that there was limited room to steer the device due to the transseptal puncture.Despite this, the first clip was successfully deployed on the mitral valve.Following deployment, the physician provided a visual observation, though it was not clear whether the observation was related to normal post-deployment settling or any other device-related finding.It was noted that the clip angle before opening was 20 degrees.The clip angle after opening was undetermined but it was noted that it was over 20 degrees.However, it was reported that the clip remained stable on the leaflets, and the outcome was deemed positive, with the patient¿s mr improving from severe to moderate, with no adverse patient consequences.After the implant of the initial clip, there was reduction in mitral regurgitation.The physician thought the clip had opened but was not sure if it was clip opened while locked.It was not confirmed.To further reduce mr, two additional mitraclip xt devices were implanted on the mitral valve, resulting in an mr grade of 2¿3.There were no adverse patient effects and no clinically significant procedural delays.The patient was reported to have been discharged.

• 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: 24430655
• Report Number: 2135147-2026-01118
• Device Sequence Number: 10392994
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)260302(10)50303A2106
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/11/2026

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: 03/02/2026
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 50303A2106
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Unknown