MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Model Number	CDS0706-NT
Medical Device Problem Codes	Material Separation (1562); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025, that the patient presented with grade 4 degenerative mitral regurgitation (mr) prolapsed posterior leaflet and mitral annular calcification (mac)anterior leaflet calcification (not in grasping zone) for a mitraclip procedure.During the procedure of mitraclip the clip was steered down to the valve but the initial grasp attempt did not adequately reduce mitral regurgitation (mr).Echocardiography (echo) revealed that the anterior leaflet gripper was unable to raise when an attempt was made to raise both the grippers.Further inspection with echo and fluoroscopy confirmed the anterior gripper remained down when the lever was retracted.The clip was retracted into the guide, revealing the gripper line was detached from the gripper.The clip was replaced with another device to complete the procedure.The mr was decreased to grade 3-4 post procedure.There were no adverse patient effects or clinically significant delay.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on 08 may 2025 that the patient presented with grade 4 degenerative mitral regurgitation (mr) prolapsed posterior leaflet and mitral annular calcification (mac)anterior leaflet calcification (not in grasping zone) for a mitraclip procedure.During the procedure of mitraclip (cds0706-nt; 50203a1004), the clip was steered down to the valve but the initial grasp attempt did not adequately reduce mitral regurgitation (mr).Echocardiography (echo) revealed that the anterior leaflet gripper was unable to raise when an attempt was made to raise both the grippers.Further inspection with echo and fluoroscopy confirmed the anterior gripper remained down when the lever was retracted.The clip was retracted into the guide, revealing the gripper line was detached from the gripper.The clip was replaced with another device to complete the procedure.The mr was decreased to grade 3-4 post procedure.There were no adverse patient effects or clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
All available information was investigated, and the reported gripper actuation issues and detached gripper line from suture knot were confirmed via device 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 available information and the returned device analysis, the reported gripper actuation issue is a cascading event of the reported detached gripper line from the suture knot.The investigation determined the detached gripper line from the suture knot to be related to a potential product quality issue.Abbott will continue to trend the performance of these devices.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 22126485
• Report Number: 2135147-2025-02913
• Device Sequence Number: 7292384
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)260202(10)50203A1004
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/21/2025

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 Expiration Date: 02/02/2026
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 50203A1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: 2 MITRACLIPS; STEERABLE GUIDE CATHETER
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White