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

Catalog Number CDS0706-NT

Device Problems Break (1069); Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported that during preparation of a mitraclip nt, while turning the knob both directions, a crunch was felt, as if the knob was already tightened.The clip would not open.Troubleshooting was performed but was not successful.Therefore, the nt was not used and was replaced.There was no clincially significant delay in the procedure.The returned device analysis revealed a gripper line break.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported difficult to open or close (clip open inability-prep) and physical resistance / sticking (arm positioner) were not confirmed via device analysis.Additionally, the actuator coupler was broken, the gripper line was broken, the clip was corroded, the actuator coupler was corroded, the l-lock tabs were scratched, the harness was deformed, and the clip introducer flush port was broken.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, the cause of the reported difficult to open or close (clip open inability-prep) appears to be due to the actuator coupler break.The cause of the observed break associated with the broken actuator coupler, the observed break associated with the broken gripper line, the observed scratched material associated with the scratched l-lock tabs, the observed deformation due to compressive stress associated with the deformed harness, and the observed break associated with the clip introducer flush port break, could not be determined.The cause of the reported physical resistance / sticking (arm positioner) associated with the arm positioner resistance could not be determined as no issue was identified during analysis.The observed corroded associated with the clip corrosion, and the observed corroded associated with the actuator coupler corrosion, were due to post-procedural shipping/ storage conditions (returned with blood on the clip and actuator coupler).There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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 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: 17819466
• MDR Text Key: 324287333
• Report Number: 2135147-2023-04185
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: 05415067037367
• 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
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2023
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 20919R2015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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