MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number	CDS0601-NTR
Medical Device Problem Codes	Positioning Failure (1158); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available information was investigated, and the reported unintended movement (sleeve steering issues) could not be confirmed via returned device analysis.The reported positioning failure (leaflet grasping - clip not implanted) and positioning failure (leaflet capture - clip not implanted) 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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and the results of analysis, a cause of the reported unintended movement (sleeve steering issues, m-knob steering), associated with the unintended m-knob response, could not be determined.The reported positioning failure (leaflet grasping - clip not implanted) was due to the reported m-knob steering issue.The reported positioning failure (leaflet capture - clip not implanted) was due to insufficient leaflet insertion.There is no indication of a product quality 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 a prolapsed posterior mitral leaflet.A mitraclip ntr was inserted and grasping was performed.However, the m knob did not work as usual.Each time the m knob was applied to reach the junction area, it would rebound slightly, and the leaflets were unable to be grasped or captured.Therefore, the clip was removed from the patient and the procedure was discontinued.No 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 NTR CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• 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: 18528411
• Report Number: 2135147-2024-00276
• Device Sequence Number: 15070278
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2024
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 30623R1057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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.
• Patient Sex: Unknown