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

Catalog Number SGC0705

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

This will be filed to report material deformation.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.One clip was successfully deployed on the mitral valve.A second clip was advanced, and the leaflets were grasped.Upon starting the deployment sequence, the lock line was unable to be removed.The physician decided to continue with the deployment of the clip.However, it was then observed the clip arms jumped open.Therefore, the physician decided to remove the clip.While attempting to remove the clip delivery system (cds) it was noted the clip was unable to be retracted into the steerable guide catheter (sgc).The decision was then made to remove both the sgc and cds at the same time.Upon removal, it was observed the septum was damaged and the soft tip of the sgc was deformed.The physician stated the damage to the septum was caused by both the sgc and cds.One additional clip was then deployed on the mitral valve, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure and no additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The returned device analysis confirmed the reported deformation due to compressive stress associated with the soft tip deformation.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and the reported deformation due to compressive stress (soft tip deformation) is related to procedural conditions associated with the open clip getting pulled forcefully in attempts to get it into the sgc and how the open clip was removed with the sgc simultaneously from the patient.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 17405858
• MDR Text Key: 320151601
• Report Number: 2135147-2023-03268
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2024
• Device Catalogue Number: SGC0705
• Device Lot Number: 30209R2071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER