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	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available information was investigated and the reported clip open during establishing final arm angle (efaa) was not confirmed via returned device 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 quality issue.The investigation was unable to determine a cause for the reported clip open during efaa.The device is included in the correction notice issued by abbott on 06 sep 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 mitraclips referenced in b5 were filed under separate medwatch report numbers.
Event or Problem Description
This is filed to report the xt clip opening while establishing final arm angle.It was reported that a mitraclip procedure was performed on (b)(6) 2022 to treat degenerative mitral regurgitation (mr) grade 4.Two mitraclip xtw's (20510r307 and 20511r166) were implanted successfully, reducing mr to grade 1-2.On (b)(6) 2023, the patient returned with recurrent mr grade 3-4 due to progression of disease.There was no evidence of tissue or chordal damage and the two implanted clips were still stable on the leaflets.An additional ntw clip (20511r242) was implanted, reducing mr to grade 2-3.On (b)(6) 2023, the patient returned with an slda of xtw clip (20510r307) and worsened mr grade 4+.An ntw clip (21013r1093) was positioned in the valve.Grasping and capturing the leaflets were noted to be difficult.After multiple attempts to grasp the leaflets, the grippers became stuck.One was stuck in the upper position and the other was stuck in the down position.It was thought contact was made with a previously implanted clip causing the gripper issue.Troubleshooting was performed, but the issue persisted.The clip was removed and exchanged.A second ntw clip (21203r2024) was attempted to be placed on the valve but experienced the same issues as the first clip.Grasping and capturing the leaflets were noted to be difficult and after multiple attempts to grasp the leaflets, the grippers became stuck.They were no longer able to move up and down.One was stuck in the upper position and the other in the down position.Troubleshooting was performed, but the issue persisted.The clip was also removed and exchanged.A third clip, xt (lot: 20613r235) was then positioned on the valve and captured the leaflets successfully.However, the clip arms refused to stay locked, and would continuously reopen from closed to 40 degrees when establishing final arm angle (efaa).This clip was removed and exchanged.A xtw clip (21019r1041) was used to complete the procedure, reducing mr to grade 1-2.There was no adverse patient effects.A delay in the procedure was reported however the delay did not result in adverse patient sequelae.No additional information was provided.

• 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: 16690844
• Report Number: 2135147-2023-01496
• Device Sequence Number: 7346901
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/06/2023

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: 20613R235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• 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 (20510R307); 1 IMPLANTED MITRACLIP XTW (20511R166); 1 IMPLANTED NTW (20511R242); STEERABLE GUIDE CATHETER
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 60 KG