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

Catalog Number CDS0702-NT

Device Problem Entrapment of Device (1212)

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

Event Date 12/08/2021

Event Type  Injury  

Event Description

This is filed to report device entrapment.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 one of the clip had detached from one of the leaflets and remained attached to the other leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 4.The physician suspected the slda occurred with the xtw clip.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional mitraclip device referenced is filed under a separate medwatch report number.

Manufacturer Narrative

The returned device analysis could not replicate the reported entrapment of device 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, a cause for the reported leaflet caught on the gripper could not be determined.The reported unexpected medical intervention was the 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: 13099074
• MDR Text Key: 287675659
• Report Number: 2024168-2021-12239
• 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: 03/19/2022
• Device Catalogue Number: CDS0702-NT
• Device Lot Number: 10317R131
• 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: 03/20/2021
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention