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

Catalog Number CDS0705-XTW

Device Problems Premature Activation (1484); Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem Embolism/Embolus (4438)

Event Date 08/08/2023

Event Type  Injury  

Event Description

This will be filed to report a clip that opened while locked, a clip that was unable to be closed, and premature clip activation.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4+ with a chordal rupture and myxomatous valve.The clip was advanced and capture attempts were performed.However, the mr reduction was not significant enough and the mitral gradient increased to 5-6 mmhg.So the physician elected to reposition the clip.Optimization was not successful so it was decided to exchange the clip.Upon attempting to retract the closed clip into the steerable guide catheter (sgc), one of the clip arms was noticed to be outside of the sgc.The clip was advanced again and attempts were made to reclose the clip, however, the clip continuously opened slightly.After multiple attempts the clip was no longer able to be closed and the clip detached from the mandrel.The embolized clip was then retracted to the sgc and the assembly was pulled through to be removed from the patient.The sgc was able to be removed from the patient, but the clip became lodged in the iliac vein.At this time the vein was cut down and the clip was retrieved.The procedure was then aborted with no clips implanted and no change in mr.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.

Manufacturer Narrative

All available information was investigated, and the reported unintended movement (clip open ¿ locked), difficult to open or close (clip close - inability), and premature activation could not be replicated in a testing environment.The clip was returned detached from the connector and the gripper was not returned.The harness was observed to be deformed.The connector hinge pin hole was observed to be scratched.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 available information, the reported unintended movement (clip open ¿ locked), associated with the clip opening slightly during the attempt of closing for cds (clip delivery system) removal, could not be determined.The reported difficult to open or close (clip close - inability), associated with the inability to close the clip after multiple attempts of clip closure, appears to be due to the clip interaction with the sgc tip preventing normal closure of clip.The reported premature activation (clip detachment) was due to the clip separation from the delivery system during removal.The observed clip separation (detachment of clip arms/legs, hinge pin and threaded stud) appears to be due to the clip interacting with the sgc tip and the subsequent troubleshooting maneuvers.The gripper was missing as it was not returned after removal from the anatomy.The harness deformation appears to be due to the troubleshooting maneuvers to retrieve the system.The scratched hinge pin hole was cascading to the clip separation.The reported clip embolism was a cascading effect of the reported premature activation.The reported patient effect of embolism, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported hospitalization, surgical intervention, removal of foreign body, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality 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: 17649367
• MDR Text Key: 322253048
• Report Number: 2135147-2023-03761
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/08/2024

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 Expiration Date: 03/05/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30307R1109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 72 KG