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

Model Number	CDS0706-NTW
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Expulsion (2933); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4+ functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, there were challenges with reaching the leaflets due to a high transeptal puncture so the steerable guide catheter (sgc) and a mitraclip were retracted into the left atrium and the transseptal was attempted to be re-punctured.When the clip was attempted to be pulled into the guide it was identified that the clip became stuck on the lip of the guide.Troubleshooting was preformed by attempting to push the clip off of the tip of the guide but it remained caught.During this time it was identified that the clip introducer was no longer attached to the clip.The clip and the sgc were fully removed from the patient, while retracting them it was observed that the clip had fully detached from the introducer and a hole was identified on the guide where the clip had been stuck to the lip of the guide.The sgc and clip were fully removed from the patient and a new sgc and mitraclip were advanced through the opposite femoral vein, the mitraclip was successfully implanted and the procedure was discontinued.The final mr was grade 1+.There was no clinically significant delays or adverse patient sequela reported.
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.
Additional Manufacturer Narrative
In this case, the reported retraction problem with the clip introducer could not be replicated in a testing environment due to the condition of the returned device (the clip was detached).The reported failure to advance and the expulsion event could also not be replicated, as these appear to be related to patient-specific or procedural/operational circumstances.Based on the information available, the reported failure to advance associated with a high transseptal puncture appears to be related to procedural circumstances.The clip introducer retraction problem appears to be related to user technique, when retracting/pulling the clip into the sgc guide, which caused the clip to become stuck on the soft tip of the sgc guide (causing it to lodge against the soft tip).The expulsion event appears related to continued forceful troubleshooting multiple attempts while the clip was stuck, leading to clip detachment.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: medical device problem code: 4008.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4+ functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, there were challenges with reaching the leaflets due to a high transeptal puncture so the steerable guide catheter (sgc) and a mitraclip were retracted into the left atrium and the transseptal was attempted to be re-punctured.When the clip was attempted to be pulled into the guide it was identified that the clip became stuck on the lip of the guide.Troubleshooting was preformed by attempting to push the clip off of the tip of the guide but it remained caught.During this time it was identified that the clip introducer was no longer attached to the clip.The clip and the sgc were fully removed from the patient, while retracting them it was observed that the clip had fully detached from the introducer and a hole was identified on the guide where the clip had been stuck to the lip of the guide.The sgc and clip were fully removed from the patient and a new sgc and mitraclip were advanced through the opposite femoral vein, the mitraclip was successfully implanted and the procedure was discontinued.The final mr was grade 1+.There was no clinically significant delays or adverse patient sequela reported.

• 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: 23430190
• Report Number: 2135147-2025-06246
• Device Sequence Number: 15845748
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: (01)05415067037435(17)251121(10)41122A1110
• 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): 01/20/2026

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 Expiration Date: 11/21/2025
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 41122A1110
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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
• Patient Sex: Unknown