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

Model Number	CDS0601-XTR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.While adjusting the trajectory, insufficient height was encountered.Drawing from operational experience, the - knob was used to compensate for the height deficiency.Subsequently, the clip came into contact with the atrial wall.After a brief observation period, a pericardial effusion was identified in the patient.The physician immediately halted the procedure and withdrew the steerable guide catheter (sgc) and clip delivery system (cds).The physician suspects that the¿-¿¿ knob of sgc exhibited abnormal torque, causing pericardial injury.The patient was subsequently transferred for surgical intervention.
Additional Manufacturer Narrative
All available information was investigated, and no functional testing/analysis was performed to investigate the reported adverse event without identified device or use problem-n/a during procedure as this is related to patient, procedural or operational circumstances.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the reported pericardial effusion was related to procedural circumstances.The reported patient effect of pericardial effusion, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported surgical intervention 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 this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.While adjusting the trajectory, insufficient height was encountered.Drawing from operational experience, the - knob was used to compensate for the height deficiency.Subsequently, the clip came into contact with the atrial wall.After a brief observation period, a pericardial effusion was identified in the patient.The physician immediately halted the procedure and withdrew the steerable guide catheter (sgc) and clip delivery system (cds).The physician suspects that the¿-¿¿ knob of sgc exhibited abnormal torque, causing pericardial injury.The patient was subsequently transferred for surgical intervention.

• 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: 22387588
• Report Number: 2135147-2025-03644
• Device Sequence Number: 8680086
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)251127(10)41127R1028
• 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): 08/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2025
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 41127R1028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown