MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0702-XTW

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507); Material Deformation (2976)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.(b)(4).The additional clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to device entrapment, single leaflet device attachment and recurrent mitral regurgitation it was reported that on (b)(6) 2021, a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An enlarged atrium was observed.An xtw was inserted, and grasping was performed at a2/p2.It was noted while in the left ventricle (lv), m-knob was slightly applied.Grasping was performed, but it was observed the anterior gripper became caught on the anterior leaflets.Troubleshooting was performed, but the gripper was unable to detach from the leaflet.It was noted this resulted in reduced visibility of the anterior leaflet.The posterior leaflet was able to be grasped; therefore, the clip was deployed on the mitral valve at the medial side of a2p2.To further reduce mr, an nt clip was inserted, and grasping was performed lateral of the first clip.However, the anterior gripper also became caught on the anterior leaflet.The clip was unable to detach from the anterior leaflet but was able to grasp the posterior leaflet, reducing mr to a grade of 2.After the procedure, the gripper line of the xtw was visually inspected.It was noted the tip of the gripper line for the anterior gripper had a different thickness than the other gripper line.On (b)(6) 2021, a transthoracic echocardiogram (tte) was performed and showed the xtw clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 4.No additional information was provided.

Manufacturer Narrative

The returned device analysis did not confirm the reported gripper line deformation.However, the gripper line was observed to be broken at the trumpet end.The reported entrapment of device, poor image resolution, and incomplete coaptation could not be replicated in a testing environment.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 all available information, the reported deformed gripper line was not confirmed.However, the gripper line was observed to be broken at the trumpet end.A cause for the broken gripper line could not be determined.A cause for the reported leaflet caught on the gripper could not be determined.The reported incomplete coaptation appears to be due to challenging patient anatomy.The reported poor imaging appears to be due to procedural conditions.The reported mitral regurgitation (mr) is a cascading event of the incomplete coaptation.Mr is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13099068
• MDR Text Key: 288199064
• Report Number: 2024168-2021-12237
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 10615R189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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 Outcome(s): Required Intervention