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

Model Number	CDS0801-XTW
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/10/2026
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 on a patient with a restricted posterior leaflet.A mitraclip xtw was inserted and grasping was performed.However, difficulties visualizing the clip occurred, he leaflets were unable to be grasped or captured, and the clip became caught in chordae.Troubleshooting was performed, and the clip was able to be freed from chordae, and the clip was removed from the patient.However, at the end of the procedure, a small flail was observed likely due to subvalvular interaction.The procedure was discontinued with no clips implanted.There was no clinically significant delay in the procedure.
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.Based on the available information, the reported positioning failures associated with leaflet grasping and leaflet capture appear to be related to a combination of patient anatomy/pathology and poor visualization.The reported poor image resolution appears to be associated with the patient anatomy, as the free edge of the posterior mitral leaflet (pml) could not be visualized on echocardiography.A cause for the reported difficult removal from the anatomy cannot be conclusively determined.Additionally, the reported patient effect of tissue injury, as listed in the mitraclip instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 50938411
• Report Number: 2135147-2026-06602
• Device Sequence Number: 10734940
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: CDS0801-XTW
• Device Catalogue Number: CDS0801-XTW
• Device Lot Number: 60507A1008
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2026
• 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: Other
• Patient Sex: Unknown