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

Catalog Number CDS0702-NTW

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Difficult to Open or Close (2921)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.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 difficulty removing the device and the single gripper actuation issue.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with a restricted posterior leaflet.It was noted that a high transseptal puncture was performed so the clip delivery system (cds) (20809r2095) could not be advanced.Subsequently, the cds was elected for exchange.Upon retracting the cds back in the steerable guide catheter (sgc) (20829r1036), the cds became stuck on the sgc tip.Both the sgc and cds were removed from the patient.After removal, it was noticed that one of the grippers would not lower.The decision was made to exchange both devices.A second cds (20907r2052) and sgc (20921r1026) were then inserted but could not reduce the mr so they were removed from the patient and the procedure was aborted with no change in mr.There was no clinically significant delay in the procedure and no adverse patient sequelae.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.Based on the available information and without the return device to analyze, the cause of the reported failure to advance associated inability to advance cds appears to be due to procedural conditions (high transseptal puncture).The cause of the reported clip getting caught on sgc tip appears to be user technique of retrieving the cds through sgc.The cause of the reported inability to lower the gripper cannot be determined.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: 16475141
• MDR Text Key: 311232883
• Report Number: 2135147-2023-00988
• 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: 03/24/2023

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: 08/09/2023
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 20809R2095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 76 KG