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

Catalog Number CDS0706-XTW

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) and posterior leaflet segment 1 (p1) flail for a mitraclip procedure.It was noted that the mitraclip xtw passed establish final arm angle (efaa) during prep.The medial side of anterior leaflet segment 1 (a1) and the p1 flail were grasped and the deployment sequence was started.During initial efaa, the clip was at a less than 30 degree clip arm angle and continuously opened to a 120 degrees clip arm angle while turning the arm positioner.Troubleshooting was performed, such as; unlocking the clip, opening to grasping arm angle, and relocking clip.The clip passed efaa and maintained a 30 degree clip arm angle.Deployment was continued, the lock line was removed, and final efaa passed.Upon release of the xtw, the clip relaxed to 30-40 degrees and some mr returned.After discussions, it was decided to accept the results and an additional clip was not implanted.The clip remained stable.The mr was reduced to grade 2.There were no adverse patient effects or clinically significant delay.

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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported unintended movement of clip open during efaa and clip open while locked.The reported unexpected medical intervention was a result of case-specific circumstance as another clip was implanted to stabilize the reported clip.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 19191665
• MDR Text Key: 341251487
• Report Number: 2135147-2024-01853
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241114(10)31113R3022
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31113R3022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2023
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 100 KG