MAUDE Adverse Event Report: Abbott Medical MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/05/2026
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.The mr was reduced to grade <1 post procedure.Approximately after 2 months of deployment, the mitraclip xtw had single leaflet device attachment (slda) from the posterior leaflet.Recurrent mr of grade 3 was reported along with dyspnea.On (b)(6) 2026, a re-interventional procedure was performed.Additional 2 mitraclips were implanted to stabilize the slda clip.The mr was reduced to grade 1-2 post procedure.There was no clinically significant delay reported.
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 the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.Based on the available information, the cause of the reported incomplete coaptation could not be determined.The reported dyspnea and recurrent mr appear to be cascading effects of the reported slda.Mr and shortness of breath, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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 ; +1(651)756-5400
• MDR Report Key: 50474443
• Report Number: 2135147-2026-05842
• Device Sequence Number: 10112356
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• UDI-Public: (01)05415067050779(17)270823(10)60223A1118
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 08/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDS0801-XTW
• Device Catalogue Number: CDS0801-XTW
• Device Lot Number: 60223A1118
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown