MAUDE Adverse Event Report: ABBOTT MEDICAL MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-XT
Medical Device Problem Codes	Positioning Failure (1158); Unintended Movement (3026)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (mr), prominent chordae for a mitraclip procedure.During the procedure, first mitraclip was implanted on the central side of anterior and posterior leaflet 2 (a2p2).It was decided to place the second clip.Clip was inserted, advanced and leaflets were grasped.Clip was locked and closed.Imager was concerned with anterior mitral leaflet insertion and interaction with secondary chordae.Anterior mitral leaflet insertion was checked.Clip was unlocked, opened with grippers down and it was observed that there was some bounce.Gripper was raised and leaflet was on but was not convinced.Clip was swung anteriorly and retracted up.Clip was shifted towards secondary chordae and the gripper was lowered.Steerable guide catheter was placed back to the neutral position.Physician had a doubt of clot.However, on evaluation it was observed that the mr worsened and the appeared to have flail with chordae.It was decided to remove the clip.Mitraclip xtw was opened and was implanted.The final mr was grade 1-2.There were no adverse patient effects or clinically significant delays reported.

• 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: 25637209
• Report Number: 2135147-2026-04387
• Device Sequence Number: 13149744
• Product Code: NKM
• UDI-Device Identifier: 05415067050762
• UDI-Public: (01)05415067050762(17)270813(10)60212A1123
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 09/25/2026

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: 60212A1123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2026
• 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: 1XMITRACLIP; STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown