MAUDE Adverse Event Report: Abbott Medical MitraClip G4 Clip Delivery System (MDR); Mitral Valve Repair Devices

Model Number	CDS0706-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.The final mr was grade 1.There were no adverse patient effects or clinically significant delays reported.\ \ on (b)(6) 2026, patient returned with declined ejection fraction, increase in fluid retention, shortness of breath.Transesophageal echocardiogram (tee) was performed, and it was determined that there was a single leaflet device attachment (slda) and the clip was no longer attached to the posterior leaflet.Mr was moderate to severe after slda.
Event or Problem Description
It was reported that on (b)(6) 2024, a patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.The final mr was grade 1.There were no adverse patient effects or clinically significant delays reported.\ \ on (b)(6) 2026, patient returned with declined ejection fraction, increase in fluid retention, shortness of breath.Transesophageal echocardiogram (tee) was performed, and it was determined that there was a single leaflet device attachment (slda) and the clip was no longer attached to the posterior leaflet.Mr was moderate to severe after slda.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified 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 information reviewed, a cause of the reported single leaflet device attachment (slda) resulting in mitral regurgitation (mr) could not be determined.Dyspnea is a cascading effect of the recurrent mr.\ the reported patient effects of mitral regurgitation (mr) and dyspnea are known possible complications associated with mitraclip procedures.The reported serious/injury/ impairment was a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50013491
• Report Number: 2135147-2026-05068
• Device Sequence Number: 9463862
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)240906(10)30907R1069
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/06/2026

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 Expiration Date: 09/06/2024
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30907R1069
• 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: 06/30/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2023
• 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 Sex: Female