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

Model Number	CDS0801-NTW
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Premature Activation (1484); Difficult to Remove (1528); Unintended Movement (3026)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (mr), restricted anterior and posterior leaflet for a mitraclip procedure.During the procedure, first mitraclip was implanted.Second mitraclip was inserted and it got stuck to the guide tip.It was unable to get the grasp and teared a chord.Physician was trying to remove the undeployed clip from the patient, and clip appeared to be moving in an unfavorable path and interacted with the guide, and the mandrel broke and the clip separated.Lockline was still in place.Cardiothoracic (ct) surgeon was consulted.It was decided to pull the guide and clip across septum from left atrium to right atrium.Guide and clip were lowered together to the lower inferior vena cava.Clip remained closed and attached to the lock line.Left groin access was obtained and snare was obtained.Clip was snared in the inferior vena cava from the left.Clip was off the lockline.Clip delivery system and guide was removed from the right groin.24fr inari guide was inserted on the right.Snared clip was pulled into the left groin.Second snare was inserted into the right groin and clip was snared.Clip was retracted to the right groin.Attempts were made to bring the clip towards the guide.Grip on the clip was lost with the snare.Clip remained in vein with minimal movement.Clip was resnared and was brought towards guide tip.Vascular surgery was consulted.Left femoral vein was cut down and removed the clip without any incident.All steps were performed as per ifu.The final mr was grade 3+.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
The device is not returning 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: 50174169
• Report Number: 2135147-2026-05375
• Device Sequence Number: 13226726
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• UDI-Public: (01)05415067050748(17)270427(10)51028A2094
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/07/2026

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-NTW
• Device Catalogue Number: CDS0801-NTW
• Device Lot Number: 51028A2094
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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: 1XMitraclip; Steerable guide catheter
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male