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

Model Number	CDS0801-XTW
Medical Device Problem Codes	Entrapment of Device (1212); Expulsion (2933)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4+ degenerative mitral regurgitation (mr), flail anterior leaflet, prolapsed posterior leaflet for a mitraclip procedure.During the procedure, difficulty was encountered in adequate leaflet insertion due to sub-optimal imaging and presence of tissue.After a couple of grasping attempts, the mitraclip xtw was deployed on both the leaflets along with tissue.Post deployment, mitraclip xtw was observed to be mobile and partially detached from the anterior leaflet.Second mitraclip was implanted laterally to first clip.The mr was reduced to grade 2-3 post procedure.On (b)(6) 2026, the patient returned symptomatic with recurrent mr of grade 3.Transesophageal echocardiogram (tee) revealed embolization of mitraclip xtw.The patient was reported to be clinically stable.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 reported from this lot.Based on the available information, the reported entrapment of device appears to be related to procedural circumstances.Additionally, the reported poor image resolution appears to be related to procedural circumstances and patient anatomy, as difficult imaging with shadowing was reported during the procedure.The reported clip expulsion (complete clip detachment) resulting in foreign body in patient and embolism/embolus are due to patient anatomy, per the physician.The reported foreign body in patient and embolism/embolus appear to be cascading effects of the reported clip expulsion.The reported mr appears to be a cascading effect of the reported clip expulsion and embolization.Additionally, the reported patient effects of embolism/embolus and recurrent mitral regurgitation, as listed in the mitraclip g5 system instructions for use, are known possible complications associated with mitraclip procedures.The reported serious injury/illness/impairment was the result 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: 50793347
• Report Number: 2135147-2026-06260
• Device Sequence Number: 9524899
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• UDI-Public: (01)05415067050779(17)270915(10)60313A1016
• 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
• 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): 10/01/2026

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: 60313A1016
• 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: 08/20/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2026
• 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: Other
• Patient Age: 87 YR
• Patient Sex: Male