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

Catalog Number CDS0702-XTW

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Material Separation (1562)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report a broken gripper line.It was reported that the patient underwent a mitraclip procedure to treat functional mitral regurgitation with a grade of 3+.The clip delivery system (cds) was advanced under the valve, but became caught in the chordae.The clip was inverted and successfully removed from the chordae.However, when the clip was retracted into the left atrium (la), it was observed under fluoroscopy that a structure was near the clip arm.The physician stated no tissue damage or thrombus occurred.It was noted that the gripper lever detached from the device during the procedure.Therefore, the clip was removed and it was observed the gripper line was broken.The physician decided to abort the procedure.Mr remained at a grade of 3+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported gripper line break and material separation was confirmed via returned device analysis.The reported difficult or delayed positioning could not be replicated in a testing environment.Additionally, the gripper lever latch and cap was observed to be detached, and the gripper lever cover tabs were observed to be broken.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 incidents reported from this lot.Based on available information, the reported material separation (detached gripper lever latch and gripper lever cap) and observed broken gripper lever cover tabs appear to be due to user technique of operating the gripper lever.The reported difficult or delayed positioning was associated with the clip getting caught in the chordae.The reported broken gripper line was related to user technique and the broken gripper lever cover tabs as pulling on a detached gripper lever cover could introduce distal bend and excessive tension onto the gripper line, resulting in gripper line breakage.There is no indication of a product quality 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: 15658587
• MDR Text Key: 302350856
• Report Number: 2135147-2022-01754
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 20406R161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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