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

Model Number CDS0706-NTW

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

This is filed to report a clip that was difficult to remove from the sgc, which broke one clip arm open, resulting in the clip being unable to close within the anatomy.It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr) and transseptal access was noted to be difficult.During a mitraclip procedure, after grasping the leaflets with the first clip, the mitral pressure gradient (mpg) increased to 8 mmhg.The mpg returned to baseline after removing the clip from the valve.During retraction of the clip into the steerable guide catheter (sgc), the clip became entangled with the sgc.One clip arm broke open and was unable to close during the entanglement.The clip was inverted and both the clip delivery system (cds) and the sgc were removed together.Another cds and sgc were used to complete the procedure.One clip was implanted with no reported issues, reducing the mr to grade 2+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

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 identified no similar complaints reported from this lot.Based on available information, the reported difficult to open or close (clip close - inability) associated with the inability to close the broken clip arm was due to the clip arm breaking.The reported break associated with the clip arm breaking was due to tension from the clip being withdrawn while caught on the sgc tip.The cause of the reported difficult to remove (cds/sgc) associated with the clip catching on the sgc tip could not be determined.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 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: 17210370
• MDR Text Key: 317947920
• Report Number: 2135147-2023-02804
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 20921A1004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 59 KG