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

Model Number	CDS0706-NT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, activated clotting time (act) was maintained at 385 seconds.After transeptal puncture a non-abbott wire was accessed across septum into left atrium.As steerable guide cathter (sgc) was being advanced, thrombus was observed on the wire in the right atrium.3000 units of heparin was administered.Sgc was removed with no adverse event.26f gore dry seal was placed and clot was successfully removed with negative suction.Sgc flushed and re-entered into body.Sgc did not cause thrombus formation, migration from its original location, or worsening of the thrombus.During the procedure, gripper orientation was performed and was successful.Mitraclip ntw advanced into left atrium(la) and during independent gripper check it was noted that the anterior gripper was unable to lower and raise.Troubleshooting was performed and was unsuccessful.The clip was replaced with another ntw clip to complete the procedure.After deployment of mitraclip ntw on lateral side, a residual jet and mitral pressure gradient of 5 mmhg was noted.An attempt was made to deploy mitraclip nt.The grippers were unable to lower and raise during independent gripper check to identify tactile gripper in the left atrium.Troubleshooting was performed and was unsuccessful.The clip was replaced with another nt clip to complete the procedure.The mr was decreased to grade 1 post procedure.There were no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
All available information was investigated, and the reported gripper actuation issue was not confirmed via returned 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 other complaints reported from this lot.The investigation was unable to determine a cause for the reported gripper actuation issue.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported on 23 april 2025 that the patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, activated clotting time (act) was maintained at 385 seconds.After transeptal puncture a non-abbott wire was accessed across septum into left atrium.As steerable guide catheter (sgc) was being advanced, thrombus was observed on the wire in the right atrium.3000 units of heparin was administered.Sgc was removed with no adverse event.26f gore dry seal was placed and clot was successfully removed with negative suction.Sgc flushed and re-entered into body.Sgc did not cause thrombus formation, migration from its original location, or worsening of the thrombus.Gripper orientation was performed and was successful.Mitraclip (cds0706-ntw; 50121a1050) advanced into left atrium(la) and during independent gripper check it was noted that the anterior gripper was unable to lower and raise.Troubleshooting was performed and was unsuccessful.The clip was replaced with another ntw clip to complete the procedure.After deployment of mitraclip ntw on lateral side, a residual jet and mitral pressure gradient of 5 mmhg was noted.An attempt was made to deploy mitraclip nt (cds0706-nt; 41203a1086).The grippers were unable to lower and raise during independent gripper check to identify tactile gripper in the left atrium.Troubleshooting was performed and was unsuccessful.The clip was replaced with another nt clip to complete the procedure.The mr was decreased to grade 1 post procedure.There were no clinically significant delay or adverse patient effects.No additional information was provided.

• 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: 22038024
• Report Number: 2135147-2025-02589
• Device Sequence Number: 15481919
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)251203(10)41203A1086
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/26/2025

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: 12/03/2025
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 41203A1086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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 Sex: Unknown