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

Model Number CDS0706-NTW

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/02/2022

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 leaflet stuck on the gripper, causing a gripper actuation issue and tissue injury.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade of 4+.The clip was advanced to the mitral valve.The anterior leaflet at some point became stuck on the anterior gripper when attempting to grasp the leaflets.Troubleshooting was performed, however, it was not possible to see the grippers raising and lowering like normal on echocardiogram.The fluoroscopy was pulled up, the clip was inverted and the gripper element could be seen on the anterior side to not be raising and lowering like it should.More maneuvering was performed to attempt to get off the anterior leaflet.The physician pulled the clip delivery system (cds) into the atrium and the gripper element finally released from the leaflet, however, the leaflet was damaged during that process.After removal from the patient, the gripper line on that gripper was completely missing.The grippers had worked fine during preparation.The procedure was aborted with mr remaining at grade 4.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 incidents reported from this lot.Based on available information and without the device to analyze, the reported image resolution poor was associated with imaging difficulty.The cause of the reported difficult to open or close (gripper actuation ¿ single) associated with the gripper actuation issue was due to the gripper line breaking.The cause of the reported break (cable break) associated with the gripper line break, and the reported unspecified tissue injury (no treatment) associated with the supposed leaflet injury, appear to be due to the difficulty in removing the gripper from anatomy.The cause of the reported difficult to remove (anatomy) associated with the gripper becoming stuck on the leaflet was due to procedural circumstances during positioning (low tsp, poor visualization) in conjunction with challenging patient anatomy (restricted leaflets).The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report the leaflet stuck on the gripper, causing a gripper actuation issue and tissue injury.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade of 4+.The clip was advanced to the mitral valve.The anterior leaflet at some point became stuck on the anterior gripper when attempting to grasp the leaflets.Troubleshooting was performed, however, it was not possible to see the grippers raising and lowering like normal on echocardiogram.The fluoroscopy was pulled up, the clip was inverted and the gripper element could be seen on the anterior side to not be raising and lowering like it should.More maneuvering was performed to attempt to get off the anterior leaflet.The physician pulled the clip delivery system (cds) into the atrium and the gripper element finally released from the leaflet, however, the leaflet was damaged during that process.After removal from the patient, the gripper line on that gripper was completely missing.The grippers had worked fine during preparation.The procedure was aborted with mr remaining at grade 4.Subsequent to the initial report, it was noted that there had been difficulties seeing the anterior clip arm due to shaft positioning and shadowing.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: 15997174
• MDR Text Key: 305623435
• Report Number: 2135147-2022-02620
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 21027R2057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Male