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

Model Number	CDS0701-XT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is filed to report the xt mitraclip opening during establishment of final arm angle.It was reported that a mitraclip procedure was performed on (b)(6) 2022, to treat functional mitral regurgitation (mr) grade 3-4.An xtw clip (20817r1042) was successfully implanted.Imaging was difficult.Approximately 20 minutes was spent trying to confirm capture of the leaflet with the posterior gripper.The clip was placed, reducing mr to trace.After reviewing the 3d image post deployment, it appeared that the clip may have been partially grasping leaflet and part of the cleft.However, the clip was stable and no additional clips were implanted.On (b)(6) 2023, the patient returned with a mr grade of 4 and the originally implanted clip was detached from the posterior leaflet (single leaflet device attachment (slda)).Tissue damage could not be ruled out.The slda was attempted to be stabilized with an xt mitraclip (20614r129).There were slight imaging issues.The xt clip was positioned medially to the slda.However, the clip opened during the second establishment of final arm angle (efaa).The clip was able to be re-opened, inverted, and removed from the body.A replacement xt clip was placed medial to the slda and a nt clip was placed lateral to the slda, reducing mr to grade 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.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 did not indicate a lot-specific product issue.All information was investigated and based on information provided and without the device to analyze, a cause for the reported unintended movement associated with clip opening while establishing final arm angle (efaa) could not be determined.Image resolution poor is related to procedural conditions as slight visualization difficulty was reported.The device is included in the correction notice issued by abbott on (b)(6) 2022 for clips not being able to establish final arm angle (efaa) and/or clip opening while locked (cowl) with the mitraclip and triclip delivery system(s).The additional mitraclip will be filed under a separate medwatch report number.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16406307
• Report Number: 2135147-2023-00604
• Device Sequence Number: 20292311
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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: 06/13/2023
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20614R129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2024168-9/6/2022-003-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP (XTW).; STEERABLE GUIDE CATHETER.
• Patient Sex: Unknown