MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G5 DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0801-NTW
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Difficult to Open or Close (2921); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) for a mitraclip procedure.During the procedure, grasping was made and mean gradient was too high to implant the clip, it was decided to remove the clip and discontinue the procedure due to small valve area.Clip was inverted and retracted into the left atrium.Clip was then locked, closed tightly to retract it into the guide.Upon retracting the clip into the guide, clip was caught at the soft tip of the guide, and the clip was sprung opened to about 120 degrees and got disconnected from the mandrel.Physician was able to retract one clip arm into the guide and pull the guide and the clip delivery system together, back into the septum and into the right atrium.It was pulled down the groin and out of the patient successfully.The final mr was grade 4.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
In this case, returned device analysis identified a broken actuator coupler.The reported premature activation, difficult to remove the cds (clip becoming caught on the sgc soft tip), clip jumping and clip opened while locked could not be replicated in a testing environment due to the condition of the returned device (the actuator coupler was broken, and the clip was hanging from the lock line and was not attached to the cds).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All information was investigated, and a cause for the reported clip getting caught on the sgc soft tip resulting in the clip jumping open, clip opened while locked, actuator coupler break and premature activation of the clip cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (mr) and small valve area for a mitraclip procedure.During the procedure, grasping was made and mean gradient was too high to implant the clip, it was decided to remove the clip and discontinue the procedure due to small valve area.Clip was inverted and retracted into the left atrium.Clip was then locked, closed tightly to retract it into the guide.Upon retracting the clip into the guide, clip was caught at the soft tip of the guide, and the clip was sprung opened to about 120 degrees and got disconnected from the mandrel.Physician was able to retract one clip arm into the guide and pull the guide and the clip delivery system together, back into the septum and into the right atrium.It was pulled down the groin and out of the patient successfully.The final mr was grade 4.There were no adverse patient effects or clinically significant delays reported.On 27 march 2026, device was returned and during device analysis it was observed that silicone valve of the guide was torn.

• 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 ; 6517565400
• MDR Report Key: 24802119
• Report Number: 2135147-2026-02211
• Device Sequence Number: 10682160
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• UDI-Public: (01)05415067050748(17)270517(10)51114A1044
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 51114A1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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: STEERABLE GUIDE CATHETER.
• Patient Age: 76 YR
• Patient Sex: Female