MAUDE Adverse Event Report: Abbott Medical MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-XT
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.A mitraclip xtw was inserted and deployed on the mitral valve.A second clip, a mitraclip xt, was then prepared for use and inserted.However, during placement of the second clip, the clip dove slightly lateral.It was suggested to correct the clip by applying the m knob.However, the physician decided to open the clip first and then move the clip, which resulted in the clip becoming caught on anatomy.Troubleshooting was performed.It was noted that removing m knob did not result in the clip moving due to the chordal interaction.However, the clip was unable to be removed.Although the clip became caught in chordae, it was able to grasp both leaflets.The second clip was then repositioned closer to the first clip, the leaflets were able to be grasped, and the clip was deployed on the mitral valve.It was noted that both clips were attached to both leaflets, with chordae.The clip was stable on the leaflets.The procedure was completed, and the mr was reduced to a grade of 1.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: MitraClip G5 Delivery System
• 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 ; +1(651)756-5400
• MDR Report Key: 50122628
• Report Number: 2135147-2026-05291
• Device Sequence Number: 21464642
• Product Code: NKM
• UDI-Device Identifier: 05415067050762
• UDI-Public: (01)05415067050762(17)270615(10)51216R1100
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDS0801-XT
• Device Catalogue Number: CDS0801-XT
• Device Lot Number: 51216R1100
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2025
• 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: 1 Implanted MitraClip; Steerable guide cathete
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown