MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G5 DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0801-NTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026, that the patient presented with grade 4+ functional mitral regurgitation (mr), and restricted posterior leaflet for a mitraclip procedure.During the procedure, a mitraclip was successfully implanted.First mitraclip had single leaflet device attachment(slda) from the posterior leaflet.Per the physician, the slda due to the pre-existing patient anatomy of thin and tethered leaflets.Another mitraclip was implanted to stabilize the slda clip.The mr was reduced to grade <1 post procedure.There was no clinically significant delay reported.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.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 the information reviewed, a cause for the reported incomplete coaptation - single leaflet device attachment (slda) appears to be related to patient morphology/pathology.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 on (b)(6) 2026 that the patient presented with grade 4+ functional mitral regurgitation (mr), and restricted posterior leaflet for a mitraclip procedure.During the procedure, a mitraclip was successfully implanted.First mitraclip had single leaflet device attachment(slda) from the posterior leaflet.Per the physician, the slda due to the pre-existing patient anatomy of thin and tethered leaflets.Another mitraclip was implanted to stabilize the slda clip.The mr was reduced to grade <1 post procedure.There was no clinically significant delay reported.

• Brand Name: MITRACLIP G5 DELIVERY SYSTEM
• 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: 25008500
• Report Number: 2135147-2026-02785
• Device Sequence Number: 8777452
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• UDI-Public: (01)05415067050748(17)270608(10)51208A1074
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CDS0801-NTW
• Device Catalogue Number: CDS0801-NTW
• Device Lot Number: 51208A1074
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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: Required Intervention
• Patient Sex: Unknown