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

Model Number	CDS0601-XTR
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/13/2025
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 on (b)(6) 2025, a patient presented with grade 3-4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a mitraclip xtr was attempted to be placed but was unable to adequately grasp the leaflets.Troubleshooting was preformed and multiple grasping attempts were made when it was identified that the leaflet tissue had been damaged.The clip was removed from the patient and the procedure was discontinued.The final mr remained at grade 3-4.There were no adverse patient effects or clinically significant delays reported.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 3-4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a mitraclip xtr was attempted to be placed but was unable to adequately grasp the leaflets.Troubleshooting was preformed and multiple grasping attempts were made when it was identified that the leaflet tissue had been damaged.The clip was removed from the patient and the procedure was discontinued.The final mr remained at grade 3-4.There were no adverse patient effects or clinically significant delays 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 positioning failure or poor imaging.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported positioning failure appears to be related to a combination of challenging patient anatomy (restricted posterior leaflet, large gap) and procedural conditions (difficulty visualizing clip during procedure, satisfactory results could not be achieved).The reported poor imaging is related to challenging patient anatomy (large gap), per case details).The reported tissue injury is a cascading event of the positioning failure.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication 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.

• 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: 23468136
• Report Number: 2135147-2025-06371
• Device Sequence Number: 18376576
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260528(10)50528R1053
• 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): 12/02/2025

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: 05/28/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50528R1053
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown