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

Model Number	CDS0801-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
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 was then inserted and advanced to the left ventricle and positioned medial to the first clip.However, it was observed that the clip was too far away.Therefore, the clip was inverted and brought back into the atrium.Once the clip returned to the atrium, it was observed that the first clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the clip, the second clip, the mitraclip xt, was repositioned and deployed on the lateral side of the first clip.To further stabilize the slda clip, a third clip was then inserted and deployed on the medial side of the first clip.The procedure was completed with three clips implanted, reducing mr to a grade of 1.It was noted that the patient tolerated the procedure well.There were no adverse patient effects and 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 Medical Northpoint Reg 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50934394
• Report Number: 2135147-2026-06592
• Device Sequence Number: 9498804
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-XTW
• Device Catalogue Number: CDS0801-XTW
• Device Lot Number: 60520A1109
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2026
• 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 Sex: Unknown