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

Model Number	CDS0801-NT
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Difficult to Open or Close (2921); Unintended Movement (3026); Physical Resistance/Sticking (4012)
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
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ degenerative mitral regurgitation (mr), anterior leaflet flail with prolapse (a1), coronary artery disease (cad), hypertension (htn), hyperlipidemia (hld), chronic obstructive pulmonary disease (cpod), tricuspid regurgitation (tr), right bundle branch (rbb), transient ischemic attack (tia) for a mitraclip procedure.During the procedure, first leaflet grasp was not convinced of full leaflet insertion, and second leaflet grasp was well visualized, and it was decided to deploy the clip.Clip was deployed and slight lateral to medial, cant was noted.It was previously planned to implant the second mitraclip central to the first clip.After implanting the second mitraclip, lateral jet had worsened and it was observed that the anterior leaflet was visible outside of the clip.It was decided to implant the additional clip lateral to the first clip.Third mitraclip was down in the ventricle, grasping was completed and found the orientation was not correct.Physician opened the arm, mistakenly did not lift the grippers, tried to rotate the clip and resistance was felt.When physician realized the mistake, physician lifted the grippers and the clip spun in the ventricle becoming entangled.It was tried to free the clip and while doing so, third clip knocked the first clip, and first clip had single leaflet device attachment (slda) and the clip was no longer attached to the anterior leaflet.Third clip was able to be freed and grasped at the intended location.Imaging was difficult.The final mr was grade 1+.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 VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24802024
• Report Number: 2135147-2026-02207
• Device Sequence Number: 9943692
• Product Code: NKM
• UDI-Device Identifier: 05415067050717
• UDI-Public: (01)05415067050717(17)270125(10)50728R1122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/20/2026

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-NT
• Device Catalogue Number: CDS0801-NT
• Device Lot Number: 50728R1122
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 77 KG