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

Catalog Number CDS0706-XTW

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Difficult to Open or Close (2921)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4+ primary mitral regurgitation (mr), and a lateral posterior 2 segment flail (p2) for a mitraclip procedure.The procedure was started with a non-abbott transcatheter edge-to-edge repair (teer) device.The team attempted to grasp the leaflets for 3 hours and then discontinued use of the non-abbott device.It was decided to convert to a mitraclip procedure.A steerable guide catheter (sgc) and the first xtw was placed in the body.It was noted that grasping and capturing was difficult.During one of the grasping attempts the anterior leaflet was caught on the anterior gripper.Once the anterior leaflet came free, it appeared that the anterior gripper could not lower.The xtw was removed from the body and new xtw prepped and inserted.The second xtw was unable to grasp and capture the leaflets.Team decided to abort the case for risk of further damage to the valve.The patient is stable and being discharged today.We met with the physician today to discuss another procedural attempt.There were no adverse patient effects or clinically significant delay.

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 positioning failure (leaflet grasping - clip not implanted) and positioning failure (leaflet capture - clip not implanted), associated with difficult leaflet grasping and capturing, appears to be related to challenging anatomy with leaflet flail.The reported difficult or delayed positioning (anatomy), associated with the anterior leaflet becoming caught on the anterior gripper, was due to procedural circumstances while grasping was performed.Without the device to analyze, a cause of the reported difficult to open or close (gripper actuation - single), associated with the anterior gripper¿s inability to lower, could not be determined.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: 18572345
• MDR Text Key: 333616459
• Report Number: 2135147-2024-00344
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2024

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: 30905A1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 84 KG