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

Model Number	CDS0601-NTR
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During the procedure, it was noted that the knob of the steerable guide catheter (sgc) was not useful and caused difficulty in moving the device.In result, the clip was unable to grasp and capture the leaflets well.It was also noted that a chordal rupture had occurred.No clip was implanted and the patient was converted to surgery.
Additional Manufacturer Narrative
Na.
Event or Problem Description
It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During the procedure, it was noted that the knob of the steerable guide catheter (sgc) was not useful and caused difficulty in moving the device.In result, the clip was unable to grasp and capture the leaflets well.It was also noted that a chordal rupture had occurred.No clip was implanted and the patient was converted to surgery.
Additional Manufacturer Narrative
In this case, the reported positioning failure associated with leaflet grasping capture 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 other complaints reported from the lot.All information was investigated, and based on the information provided, a cause for the reported positioning failure associated with leaflet grasping and capture cannot be determined.Unspecified tissue injury appears to be related to the procedural conditions (leaflet grasping and capturing issues).Tissue damage/injury is a known possible complication associated with mitraclip procedures.Surgical intervention was a result of case-specific circumstances.There is no indication of a product 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: 21988184
• Report Number: 2135147-2025-02422
• Device Sequence Number: 4477986
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)250905(10)40905R1017
• 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): 06/10/2025

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: 09/05/2025
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 40905R1017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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