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

Model Number N/A

Device Problems Break (1069); Positioning Failure (1158); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/25/2022

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 gripper actuation issue, a break in the gripper line and tissue injury.It was reported that on (b)(6) 2022, a mitraclip procedure was performed for a mitral regurgitation grade 4+.It was noted that visualization during the procedure was difficult.The clip delivery system (cds) was advanced in the patient and after multiple attempts were made to grasp the leaflets, it was noticed that one of the grippers was not working.The device was removed from the patient and confirmed that the gripper line broke.It was also noted that one primary chord on the anterior leaflet appeared ruptured due to the difficulty grasping.Another clip was used to complete the procedure, reducing the mr grade to 1+.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 did not indicate a lot-specific quality issue.The investigation determined the reported inability to grasp the leaflets appears to be due to patient morphology/pathology.The reported poor image resolution was associated to visualization difficulty during the procedure.The reported gripper actuation issue was related to the reported gripper line break.However, a cause for the gripper line break cannot be determined.The tissue injury appears to be related to the grasping issue.Tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstances as no treatment was provided for the reported tissue injury.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 15259586
• MDR Text Key: 298229940
• Report Number: 2135147-2022-00828
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20222R451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other