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

Catalog Number CDS0702-XTW

Device Problem Migration (4003)

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

Event Date 04/04/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4, pre-existing chordal rupture, prolapsed anterior leaflet, and flail.A mitraclip xtw (31017r3004) was inserted and deployed centrally on the mitral valve.However, after deployment, the clip showed signs of partial clip movement off the anterior leaflet.It was noted that prior to deployment, the clip was attached to both anterior and posterior leaflets, but once deployed, the clip changed position.It had flipped and rotated from the initial position but remained attached to both leaflets.To stabilize the partially moved clip, a mitraclip xt (30501r1046) was then deployed medial to the first implanted clip.After deployment, the clip remained attached to clip delivery system (cds).Troubleshooting was performed to free the clip but was not successful.An attempt to remove the anterior gripper line was made, but the posterior clip arm remained stuck in the clip.Pulling on the gripper line did not free the clip.A small unintentional pull on the stabilizer occurred, which caused the gripper line to enter the cds and freed the clip from cds.To salvage access to the gripper line, the tube of the gripper line was broken.However, this did not resolve the issue.The cds was removed from the steerable guide catheter (sgc), leaving the gripper line extending out of the sgc.To remove the gripper line, a guidewire extension was inserted to attach to the gripper line but was not successful.A goose neck snare was then used to remove the gripper line.To further reduce the mr, another mitraclip xtw was implanted without issues.The procedure was completed with three clips implanted, reducing the mr to a grade of 3.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 19176223
• MDR Text Key: 340970588
• Report Number: 2135147-2024-01828
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)241016(10)31017R3004
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 04/24/2024

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 Catalogue Number: CDS0702-XTW
• Device Lot Number: 31017R3004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White