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

Catalog Number CDS0706-XTW

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921); Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr) with an aorta hugger for a mitraclip procedure.During device unpackaging of an xtw, the delivery catheter (dc) handle was rotated in the package as normal.The dc handle was straightened, and it continued to turn.Preparation was completed per instructions for use (ifu) and there were no further issues.As the clip delivery system (cds) was inserted and steered to the valve, additional curves were applied.Due to the aorta hugger, a half turn of m knob was applied.Additionally, a half turn of a knob and a quarter turn of + knob was applied during positioning.It was noted the physician applied a decent amount of torque to the dc handle and had to undo some rotation because it felt as it was spinning.When positioned above the valve, there was difficulty opening the clip.There were 3 attempts to troubleshoot.On the third attempt, after retracting the lock lever farther past the blue line, the clip opened.The leaflets were grasped.There was a lot of tension noted on the device.The clip could not close all the way down.There was tension noted during dc handle retraction.The clip was removed and replaced.The replacement xtw was implanted successfully.There was residual mr on anterior 3 and posterior 3 leaflets (a3/p3).An nt was selected to target the residual mr.The device was prepped with no issues.It was noted that the arm positioner was not at neutral during initial insertion into the steerable guide catheter (sgc).The physician noted that within the anatomy the system was tight.The arm positioner was turned to neutral.The clip needed additional height and a knob to go medial and pass the first clip.Once above the valve, the clip could not open.Troubleshooting was performed 4-5 times, and the clip could not open.The clip was removed without issues, and a replacement nt completed the procedure.The mr was reduced to grade 1+.There were no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported difficult to close clip, difficult to open clip, arm positioner resistance, dc handle retraction issue, and unintended movement were not confirmed via returned device analysis.Additionally, a scratched dc handle was observed.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 returned device analysis, the cause of the reported difficult to close clip, difficult to open clip, arm positioner resistance, dc handle retraction issue, and unintended movement were unable to be determined.The observed scratched dc handle is likely a result of procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18265326
• MDR Text Key: 329671542
• Report Number: 2135147-2023-05324
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30713A1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male