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

Model Number	CDS0601-XTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Angina (1710); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+ on a patient with a prolapsed posterior leaflet, thick leaflets, a calcified valve annulus, and a previous transcatheter aortic valve implant (tavi) surgery.A steerable guide catheter (sgc) and a mitraclip xtr were inserted without issues.However, limited bending manipulation with the sgc occurred, which resulted in difficulty with positioning of the sgc and uneven clamping with the mitraclip xtr.The mitraclip xtr was ultimately deployed on the mitral valve, reducing mr to a grade of 1+.After the sgc was removed from the patient, the sgc was tested and the sgc tip was bending normally.On (b)(6) 2026, one week post procedure, the patient developed chest tightness.An ultrasound was performed and revealed that the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 4+.The patient was reported to be stable.
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 available information, a cause for the reported incomplete coaptation - single leaflet device attachment (slda) appears to be related to patient morphology/pathology.The reported chest tightness and recurrent mitral valve insufficiency/ regurgitation (mr) appears to be cascading effects of the reported slda.Chest tightness and mr are known possible complications associated with mitraclip procedures.The reported serious injury/illness/impairment 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 that on (b)(6) 2026, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+ on a patient with a prolapsed posterior leaflet, thick leaflets, a calcified valve annulus, and a previous transcatheter aortic valve implant (tavi) surgery.A steerable guide catheter (sgc) and a mitraclip xtr were inserted without issues.However, limited bending manipulation with the sgc occurred, which resulted in difficulty with positioning of the sgc and uneven clamping with the mitraclip xtr.The mitraclip xtr was ultimately deployed on the mitral valve, reducing mr to a grade of 1+.After the sgc was removed from the patient, the sgc was tested and the sgc tip was bending normally.On (b)(6) 2026, one week post procedure, the patient developed chest tightness.An ultrasound was performed and revealed that the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 4+.The patient was reported to be stable.

• Brand Name: MITRACLIP
• 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: 24942067
• Report Number: 2135147-2026-02593
• Device Sequence Number: 12998448
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)261121(10)51120R1077
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 51120R1077
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown