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

Catalog Number CDS0705-NTW

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problems Low Blood Pressure/ Hypotension (1914); Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/03/2024

Event Type  Injury  

Manufacturer Narrative

All available information was investigated, and the reported entrapment of device (clip caught on chordae), improper or incorrect procedure or method (failure to follow steps / instructions), and difficult to open or close (gripper actuation - both) could not be replicated in a testing environment.In addition, the actuator coupler was observed corroded, and the l-lock tabs were observed to be scratched.One gripper line was 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 complaints reported from this lot.Based on available information, a cause for the reported difficult to open or close (gripper actuation - both), associated with both grippers failing to lower after grasping, could not be determined.The reported entrapment of device (clip caught on chordae), associated with the clip becoming stuck in the chordae and unable to be removed, was due to procedural circumstances during retraction of the clip implant.The reported improper or incorrect procedure or method was associated with the user not confirming the gripper orientation while in the left atrium.The observed gripper line break appears to be related to troubleshooting maneuvers performed to free the entrapped device, as excessive tension could have been introduced onto the gripper line.The observed scratched l-lock tabs also appears to be due to troubleshooting to resolve device entrapment.The observed actuator coupler corrosion was related to salinity and moisture remained inside the system post procedure.The cause of the reported unchanged mr, low blood pressure, and mitral stenosis could not be determined.The reported patient effects of mitral regurgitation, mitral stenosis, and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions, surgical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.Mitraclip ntw (lot: 30508r1067) was advanced to the valve.Gripper orientation was not performed and the clip was advanced into the ventricle before imaging was optimized in peripheral view.After grasping, both grippers failed to lower.Also during grasping, the steerable guide catheter slipped out of the septum into the right atrium and caused an atrial septal defect (asd).The clip was then attempted to be retracted to the left atrium, but it became stuck in the chordae and could not be removed via standard troubleshooting.Non-standard troubleshooting was also attempted, such as shaking the clip which was also unsuccessful.The clip had to be implanted a2/p2 lateral with both leaflets and chordae.After deployment, the mean pressure gradient was 7 mmhg and blood pressure dropped, with mr remained unchanged grade 4.The mitral stenosis was too severe for the patient to endure so an intra-aortic balloon pump (iabp) was placed and the patient was put on extracorporeal membrane oxygenation (ecmo).The next day (b)(6) 2024, a mitral valve replacement surgery was performed, along with an atrial septal defect closure.

• 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: 18791354
• MDR Text Key: 336396126
• Report Number: 2135147-2024-00876
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/27/2024

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: 05/06/2024
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 30508R1067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 53 KG