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

Model Number	CDS0601-XTR
Medical Device Problem Codes	Positioning Failure (1158); Entrapment of Device (1212); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/01/2025
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 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4, large gap, and enlarged atrium.A mitraclip xtr was inserted and deployed on the mitral valve.A second clip, a mitraclip xtr (50717r1017) was inserted and advanced under the valve.However, difficulties capturing the anterior and posterior leaflets occurred, the clip became caught in chordae.And the clip was unable to be freed from chordae.Therefore, the clip was deployed where it was stuck, attached to the anterior leaflet and detached from the posterior leaflet (single leaflet device attachment/slda).No additional clips were implanted, and the mr remained at a grade of 4.There were no adverse patient effects and no clinically significant delay in the procedure.
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 available information, the reported single leaflet device attachment (slda) was due to the clip being entangled in chordae.The reported difficult positioning and subsequent entanglement in chordae were due to challenging patient anatomy.The reported unchanged mitral regurgitation was a cascading effect of the slda.Mitral regurgitation is listed in the instructions for use as a known possible complication associated with the mitraclip procedure.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4, large gap, and enlarged atrium.A mitraclip xtr was inserted and deployed on the mitral valve.A second clip, a mitraclip xtr (50717r1017) was inserted and advanced under the valve.However, difficulties capturing the anterior and posterior leaflets occurred, the clip became caught in chordae.Troubleshooting was performed, and the clip was unable to be freed from chordae.Therefore, the clip was deployed where it was stuck, attached to the anterior leaflet and detached from the posterior leaflet (single leaflet device attachment/slda).No additional clips were implanted, and the mr remained at a grade of 4.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 23889694
• Report Number: 2135147-2025-07707
• Device Sequence Number: 15854310
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260717(10)50717R1017
• 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: 2025
• 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): 02/16/2026

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 Expiration Date: 07/17/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50717R1017
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• 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; Other
• Patient Sex: Unknown