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

Model Number	CDS0706-NTW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
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, air bubble was observed in the sleeve of delivery catheter handle while advancing into mitral valve.The clip was replaced with another device to complete the procedure.The mr was reduced to grade 2+ post procedure.There was no clinically significant delay or adverse patient effects.
Additional Manufacturer Narrative
The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
All available information was investigated, and the reported leak was not confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this issue.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, a cause for the reported leak could not be conclusively determined.The reported serious injury/ illness/ impairment and medication required were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: health effect-clinical code: 4582.Health effect- impact code: 2199.Codes added: health effect-clinical code: 4644, 4614.
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, air bubble was observed in the sleeve of delivery catheter handle while advancing into mitral valve.The clip was replaced with another device to complete the procedure.Additional anesthetic support was provided to the patient.The mr was reduced to grade 2+ post procedure.There was no clinically significant delay or adverse patient effects.

• 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 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: 23729152
• Report Number: 2135147-2025-07185
• Device Sequence Number: 9742900
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: (01)05415067037435(17)260218(10)50219R2063
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/10/2026

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: 02/18/2026
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 50219R2063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown