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

Catalog Number CDS0702-XTW

Device Problems Break (1069); Difficult to Insert (1316); Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Difficult to Open or Close (2921); Unintended Movement (3026)

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

Event Date 02/28/2024

Event Type  Injury  

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.Based on available information, the cause of the reported difficult to insert, difficult to advance, difficult retraction, and cowl were unable to be determined.The reported unable to open clip in anatomy is likely a cascading event of the reported improper or incorrect method or procedure.The reported broken clip was due to the user using force to retract the clip while slightly open (improper or incorrect method or procedure).The reported improper or incorrect procedure or method was associated with the user curving the device 100 degrees and using retracting the clip while slightly open.It should be noted that the mitraclip instructions for use (ifu) states, ¿do not deflect the sleeve tip more than 90 degrees as device damage may occur.Use of damaged product may result in cardiac injury." it also states, ¿fully close the clip arms and continue to turn the arm positioner until it is no longer possible to rotate the arm positioner.Return the arm positioner to neutral.Warning: failure to follow these step prior to retraction into the guide may result in device damage, inability to remove the cds and/or vascular and cardiac injury.¿ the reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: device code 2017 - failure to follow steps / instructions.

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4.A mitraclip xtw was selected for treatment, but while inserting the clip and while advancing the clip delivery system (cds) through the guide, resistance was encountered.The xtw was inserted into the left atrium (la), in front of the valve, but it was unable to be opened.Therefore, a decision was made to remove the clip delivery system (cds) from the patient.However, difficulties retracting the clip into the steerable guide catheter (sgc) occurred.The clip had opened slightly.Therefore, the clip did not fit into the sgc.Force was applied to recapture the cds, but the clip broke, remaining only attached to the lock line.A lasso catheter (cross-over) was inserted to remove the cds.The cds was successfully removed from the patient.It was noted that during the procedure, the cds was curved 100 degrees.Two mitraclips were then implanted with a good result, reducing the mr to trace.There was no clinically significant delay in the procedure.

• 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: 18932903
• MDR Text Key: 338023935
• Report Number: 2135147-2024-01234
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 31002R1058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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