MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Model Number	CDS0701-XT
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is filed to report inability to close a clip.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4+ and a restricted posterior leaflet.A mitraclip xtw was placed in the medial jet without incident, reducing mr to a grade of 2-3.A mitraclip xt (20613r104) was then inserted, but after grasping both leaflets and attempting to close the xt, the clip would not close.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed.In the physician¿s opinion, the clips limited ability to close was likely due to the clip caught in chordae.A mitraclip ntw (30109a1012) was then used to address the lateral jet, but became caught in the chordae, and caused an increase in mr to a grade of 3-4.The physician was unable to determine if any tissue damage occurred.The clip was removed and replaced with an xtw clip.This clip was successfully implanted, reducing mr to a grade of 2.There was no clinically significant delay in the procedure.No additional information was provided.
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 this event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and based on information provided the reported difficult or delayed positioning associated with the clip interacting with the anatomy (chordae) resulting in inability to close the clip appears to be related to patient conditions (fully blunted pulmonary vein, restricted posterior mitral leaflet, mitral valve area of 5.54 cm2, and low transseptal height of 3.8mm/hg).There is no indication of a product issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17059370
• Report Number: 2135147-2023-02440
• Device Sequence Number: 20124791
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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: 06/12/2023
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20613R104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 98 KG