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

Catalog Number CDS0702-XTW

Device Problem Expulsion (2933)

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report the clip detaching from the valve and embolizing, requiring intervention.It was reported that a mitraclip procedure was performed on (b)(6) 2023 to treat functional mitral regurgitation (mr) grade 4.Two mitraclip xtw clips ( 20725r1043 and 20815r2075) were implanted successfully.Good grasps and insertion was achieved and the mr was reduced to grade 1-2.Seven days post procedure on (b)(6) 2023, the patient became symptomatic with syncope and arrhythmia.Echocardiogram was performed and it revealed that the xtw clip (20815r2075) had fully detached from the valve.Tissue damage to the valve was suspected.A ct scan was performed and found the clip embolized to the common iliac artery.Endovascular removal of the clip was performed.No additional information was provided.

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.The investigation was unable to determine a cause for the reported clip expulsion.The reported embolism, recurrent mitral regurgitation (mr), tissue injury and arrhythmia were due to the clip expulsion.The syncope appears to be a cascading effect of the arrhythmia.Embolism, mr, tissue injury, arrhythmia, and syncope are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization, surgical intervention and removal of foreign body were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previously filed report, additional information was received: after the surgical intervention was completed, it was noted that mr was recurrent grade 3-4.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16644898
• MDR Text Key: 312337794
• Report Number: 2135147-2023-01402
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 04/27/2023

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: 08/15/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 20815R2075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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: 1 IMPLANTED MITRACLIP XTW (20725R1043)
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention