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

Catalog Number CDS0705-XTW

Device Problems Difficult to Insert (1316); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem Air Embolism (1697)

Event Date 01/04/2024

Event Type  Injury  

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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.H6: device code 2017 - failure to follow steps / instructions.

Event Description

It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a posterior prolapse.A steerable guide catheter (sgc) (31102r1036) and an xtw clip (31016r1083) were inserted and advanced to the mitral valve.It was noted inserting the clip into the sgc was difficult as resistance was felt when inserting and lining up the blue alignment markers.However, bubbles were observed in the left atrium (la) and in the chamber of the sgc.It was noted the three-way stopcock had not been fully closed on the sgc.Therefore, the clip was removed, and aspiration was performed which removed the air from the anatomy.It was noted the lock lever caps were turned more than half a turn in the open direction to de-air the clip delivery system (cds).The clip was then re-inserted and deployed.A second xtw clip was successfully implanted, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.

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 other complaints reported from this lot.The investigation was unable to determine a cause for the reported difficult to insert.The reported user error (improper or incorrect procedure or method) was due to the user turning lock lever cap more than half a turn in the open direction to de-air the clip delivery system (cds) and reinserting the cds when there was an issue with the device.The reported leak appears to be related to the reported user error (improper or incorrect procedure or method) in conjunction of the three-way stopcock on the guide not been fully closed.It should be noted the mitraclip system g4 instruction for use (ifu) warns ¿do not use the device if damage is detected.Used of damaged product can result in air embolism, implant or device component embolization, vascular and/or cardiac injury and instructs to loosen the lock lever cap to de-air.Do not turn the lock lever cap more than ½ turn in the open direction.After de-airing, tighten the lock lever cap." the reported air embolism appears to be related to the reported leak.Air embolism is listed in the ifu as a known possible complication associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance.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: 18587824
• MDR Text Key: 333895969
• Report Number: 2135147-2024-00377
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/08/2024

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: CDS0705-XTW
• Device Lot Number: 31016R1083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White