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

Model Number	CDS0601-XTR
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received.However, 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 degenerative mitral regurgitation (mr) with a grade of 4+ and prolapsed posterior leaflet.A mitraclip xtr was inserted, advanced into the left ventricle (lv), and grasping was performed.However, difficulties visualizing the clip occurred, and the clip became caught in chordae.Troubleshooting was performed, and the clip was freed.However, chordae rupture and leaflet damage were observed.Therefore, the clip was removed from the patient.However, after removing the steerable guide catheter (sgc), it was observed that the interatrial septum was damaged.The procedure was discontinued.No clips were implanted, and the mr remained at a grade of 4+.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The reported difficult to remove from the anatomy and image resolution poor could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history identified no similar complaints from the lot.All information was investigated, and the reported difficult to remove from the anatomy appears to be related to a combination of challenging anatomy and procedural conditions.Image resolution poor was due to the patient's anatomy (leaflet prolapse).Unspecified tissue injury appears to be related to procedural conditions.Tissue damage/injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Serious injury / illness / impairment was a 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 degenerative mitral regurgitation (mr) with a grade of 4+ and prolapsed posterior leaflet.A mitraclip xtr was inserted, advanced into the left ventricle (lv), and grasping was performed.However, difficulties visualizing the clip occurred, and the clip became caught in chordae.Troubleshooting was performed, and the clip was freed.However, chordae rupture and leaflet damage were observed.Therefore, the clip was removed from the patient.However, after removing the steerable guide catheter (sgc), it was observed that the interatrial septum was damaged.The procedure was discontinued.No clips were implanted, and the mr remained at a grade of 4+.There was 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: 22829692
• Report Number: 2135147-2025-04611
• Device Sequence Number: 4464002
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260303(10)50228R1013
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/29/2025

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: 03/03/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50228R1013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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