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

Model Number	CDS0706-XT
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and friable leaflets.A mitraclip xtw was inserted and deployed on the mitral valve.To further reduce mr, a mitraclip xt was inserted, but after several grasping attempts, the mr worsened, and it was observed that the posterior leaflet was torn.A decision was made to move closer to the first clip, but the clip appeared to be stuck and was unable to be retracted to the left atrium (la).Therefore, the clip was deployed where it was stuck, attached to only the anterior leaflet.After deployment, it was observed that the clip had only been attached to the anterior leaflet and detached from the posterior leaflet (single leaflet device attachment/slda).The clip delivery system (cds) was removed from the patient.No additional clips were implanted, and the mr remained at a grade of 4.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for 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 did not indicate a lot-specific quality issue.Based on available information, the reported clip stuck was due to procedural circumstances (technique of positioning).The cause of the reported slda was unable to be determined.The difficult leaflet grasping was likely due to the reported tissue injury.The reported tissue injury was likely due to a combination of patient condition (friable leaflets) and procedural circumstances.The reported unchanged mr was a cascading effect of the reported tissue injury.The reported patient effects of tissue injury and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and friable leaflets.A mitraclip xtw was inserted and deployed on the mitral valve.To further reduce mr, a mitraclip xt was inserted, but after several grasping attempts, the mr worsened, and it was observed that the posterior leaflet was torn.A decision was made to move closer to the first clip, but the clip appeared to be stuck, and was unable to be retracted to the left atrium (la).Therefore, the clip was deployed where it was stuck, attached to only the anterior leaflet.After deployment, it was observed that the clip had only been attached to the anterior leaflet and detached from the posterior leaflet (single leaflet device attachment/slda).The clip delivery system (cds) was removed from the patient.No additional clips were implanted, and the mr remained at a grade of 4.There was no clinically significant delay in the procedure.

• 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: 23794958
• Report Number: 2135147-2025-07345
• Device Sequence Number: 17571088
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)260429(10)50430A1007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2026
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 50430A1007
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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: 1 IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 45 KG