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

Model Number CDS0701-XTW

Device Problems Break (1069); Material Frayed (1262); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/21/2022

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 an issue removing the lock line.It was reported that on (b)(6) 2022, a patient presented with grade 4 degenerative mitral regurgitation (mr).The lock line of a mitraclip xtw was not able to be fully removed from the clip delivery system (cds).Most of the lock line was withdrawn during deployment, but a portion was unable to be withdrawn from the cds.Deployment was continued.The clip was deployed and the cds separated from the clip.The cds was removed from the patient without issue.When the cds was removed from the guide, there was a small piece of the lock line visible at the end of the cds.The lock line was frayed at the end.It was unknown if a portion of the lock line remained in the patient or if it was fully removed with the cds.The mr was reduced to grade 2.There was no adverse patient sequelae or clinically significant delay.No additional information was provided.

Manufacturer Narrative

H6: device code 2017 - failure to follow steps / instructions.All available information was investigated, and the reported mechanical jam (lock line -inability), break (lock line-removal) and material frayed was confirmed via returned device analysis.The reported improper or incorrect procedure or method (failure to follow steps/instructions) could not be replicated in a testing environment.In addition, the lock line was observed to be knotted at the distal end.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 mechanical jam (lock line ¿ inability) was due to the observed knot.The reported material frayed was a secondary effect of the lock line break.The reported lock line break appears to be due to procedural circumstances while attempting to remove the jammed lock line.The observed knot in lock line appears to be related to user technique of unwrapping the lock line which could lead to formation of a knot.The improper or incorrect procedure or method (failure to follow steps/instructions) was associated with the user error of proceeding to clip deployment without complete removal of the lock line.The reported foreign body in patient associated with user¿s concern of a portion of lock line remaining inside patient was due to user speculation, as the lock line was returned in full length.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.

• 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: 15612078
• MDR Text Key: 301815794
• Report Number: 2135147-2022-01628
• Device Sequence Number: 1
• Product Code: NKM
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 11208R172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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