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	08/16/2023
Type of Reportable Event	Malfunction
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
This is filed to report unintended movement.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4+ and an enlarged atrium.A mitraclip ntr was used, but curvature could not be maintained while applying the m-knob, and the clip had a rebound phenomenon.The clip was removed from the patient.The procedure was completed with no clips implanted.The mr remained at grade 4+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The returned device analysis did not confirm the positioning failure associated with inability to curve/maintain the tip in ¿m¿ direction and the unintended movement of the clip not maintaining the position (rebound phenomenon).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints from the lot.Based on information provided and the results of the returned device analysis (unable to confirm the reported issues), a cause for the reported positioning failure associated with inability to curve/maintain the tip in ¿m¿ direction and the unintended movement of the clip not maintaining the position (rebounding) could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 17705484
• Report Number: 2135147-2023-03903
• Device Sequence Number: 17683520
• 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
• 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): 10/11/2023

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: 04/10/2024
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 30410R1079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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