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

Catalog Number CDS0702-XTW

Device Problems Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr), anterior mitral leaflet (aml) flail, a lot of chordae tendinea and not a lot of space within the left ventricle to the papillary muscle head for a mitraclip procedure.During the procedure, first mitraclip xtw was prepped and inserted as per ifu.During system prep the device functioned as intended.During the first grasp attempt the anterior gripper actuation was not visualized.The gripper did not lower.Troubleshooting was performed and the clip was reopened to reconfirm if the gripper would lower.The gripper did not lower.Troubleshooting as per ifu was performed by locking the clip and unlocking again, and actuating the gripper simultaneous and independent.To be on the safe side we therefore the grasp was released to remove the clip.While trying to get free from the aml the clip was caught by the aml or in chordae tendinae.Physician managed to get the clip free, and removed the inverted clip to the left atrium.After that maneuver no additional defect of the mitral valve or leaflets was noted.With the clip in the left atrium we noted that we could see the anterior gripper lowered while the gripper lever was retracted.By actuating the gripper lever, the anterior gripper did not move up or down any longer.The clip was removed from the patient as per ifu without any complications.And a new mitraclip was prepped and used as per ifu.This new clip was positioned successfully in a2/p2 medial position, and another clip was positioned in a2/p2 central position to improve mi from pre grade 4 to post grade 1.Patient was hemodynamically stable the whole time the replacement clips were successfully implanted, no adverse patient effects or clinically significant delay.

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 or delayed positioning associate with clip caught on anatomy could not be replicated in a testing environment as it was related to patient anatomy or procedural circumstances.The reported gripper actuation issue was confirmed via returned device analysis and observed the tactile gripper line had separated from the clip (material separation) and was outside the l-lock shaft hole with the gripper line trumpet intact.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.Based on available information, the reported gripper actuation issue appears to be related to the observed gripper line separation.The investigation determined the observed gripper line separation to be related to a potential product issue.This complaint is within the scope of exception (action) 135842 as the complaint description and device code match the specific issue described in the exception.Therefore, exception (issue) 130421 and exception (action) 135842 are referenced.The exception investigation evaluated the reported issue, and the engineering group determined the root cause appears to be related to manufacturing variability within specifications leading to tolerance stack up between the gripper lines, coupler, and l-lock components.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.A cause for the reported difficult or delayed positioning associate with clip caught on anatomy cannot be determined.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: 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: 18987293
• MDR Text Key: 338720259
• Report Number: 2135147-2024-01361
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)240919(10)30920R2033
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: CDS0702-XTW
• Device Lot Number: 30920R2033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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
• Treatment: STEERABLE GUIDE CATHETER.