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

Catalog Number CDS0706-XTW

Device Problems Break (1069); Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat mitral regurgitation (mr).The patient presented with challenging anatomy and had a previous non-abbott clip attempt that failed.Due to the patient's condition, the transseptal puncture was not optimal but the steerable guide catheter (sgc) was still able to be steered down to the valve.An xtw (lot: 30920r2053) was then attempted to be implanted.Grasping was challenging.After two gripper cycles, the posterior gripper could not be confirmed to be lowering during simultaneous actuation.Troubleshooting was attempted but the gripper would not lower.The clip was removed from the patient.Upon inspection, the gripper line was not visible.A replacement xtw clip was used to complete the procedure, reducing mr to moderate.

Manufacturer Narrative

All information was investigated, and the returned device analysis confirmed the reported single gripper actuation issue and gripper line break.Positioning failure-leaflet grasping - clip not implanted, image resolution poor- n/a and improper or incorrect procedure or method- failure to follow steps / instructions could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and while the reported single gripper actuation issue appears to be related to the gripper line break, a cause for how the gripper line broke could not be determined.Positioning failure associated with leaflet grasping appears to be related to patient anatomy (wide lateral p2 (posterior) prolapse/flail with thickened, myxomatous leaflets and low transseptal puncture).Image resolution poor is related to procedural conditions associated with difficulties visualizing the clip during procedure.Improper or incorrect procedure or method/user error is associated with the user under straddling the sleeve and the radiopaque (ro) tip ring on the guide was not aligned between the ro alignment markers on the sleeve.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.The patient presented with challenging anatomy and had a previous non-abbott clip attempt that failed.Due to the patient's condition, the transseptal puncture was not optimal.The xtw (lot: 30920r2053) had to be under straddled due to the low transseptal puncture.Grasping was challenging.After two gripper cycles, the posterior gripper could not be confirmed to be lowering during simultaneous actuation.Troubleshooting was attempted but the gripper would not lower.The clip was removed from the patient.Upon inspection, the gripper line was not visible.A replacement xtw clip was used to complete the procedure, reducing mr to grade 1.

• 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 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: 18856864
• MDR Text Key: 337117468
• Report Number: 2135147-2024-01035
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)240919(10)30920R2053
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: CDS0706-XTW
• Device Lot Number: 30920R2053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 61 KG