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

Catalog Number CDS0705-XT

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

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

Event Date 03/18/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with grade 4+ degenerative mitral regurgitation (mr), atrial fibrillation, and a pre-existing chordal rupture for a mitraclip procedure.The first clip was attempted to be placed on the anterior commissure.Perpendicularity to the line of coaptation was off by five degrees (counterclockwise).The mr was reduced to grade 1-2.The first clip was released and the tip of the clip pushed out to the left atrium during diastole.The clip was oriented medially.The movement of the clip was stable, but mr on the medial side of the clip increased.The posterior mitral leaflet (pml) was gradually becoming less inserted.A second clip was used to stabilize the first clip and reinforce the tip to be positioned towards the left ventricle.This was a challenge and the mr worsened from the commissure to grade 4+ or more.Considering the possibility that the first clip could come off completely, the side of posterior leaflet segment 2 (p2) entered the left ventricle in effort to not interfere with the 1st clip.The p2 lateral side was controlled by the second clip.The second clip was implanted and there was no observed interaction between the two clips.The mr was reduced to grade 4.There was no harm to the patient during the procedure.Follow-up and surgical procedures were considered, and the physicians were concerned of hemolysis by mr from the commissure.There were no adverse patient sequelae.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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.The investigation was unable to determine a cause for the reported migration (partial clip movement).The reported improper or incorrect procedure or method was due to the perpendicularity to the line of coaptation was off by 5 degrees.The reported unexpected medical intervention was a result of case-specific circumstance as another clip was implanted to stabilize the clip and reinforce the tip to be positioned towards the left ventricle.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 19086949
• MDR Text Key: 339897774
• Report Number: 2135147-2024-01632
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288623
• UDI-Public: (01)08717648288623(17)240917(10)30915R1096
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/06/2024

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: CDS0705-XT
• Device Lot Number: 30915R1096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2023
• 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: 89 YR
• Patient Sex: Male