MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-NTR

Device Problems Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2020

Event Type  malfunction  

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.

Event Description

This is filed to report the gripper actuation issue.It was reported that during preparation of the mitraclip delivery system (cds) the gripper arms did not fully lower, they stayed at approximately 60 degrees.The clip also failed to establish final arm angle (efaa).The clip opened during efaa to 30-40 degrees.There was no patient involvement, the cds was not used and was replaced.There was no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The returned device analysis did not confirm the reported difficult to open or close/gripper actuation and unintended movement (efaa) as the device functioned as intended.Potential causes for gripper actuation issue are due to unintended curves on the device applied by the user or damage to the internal components caused by increased tension on the system and actuating the grippers more often than needed or not following the steps outlined in the instruction for use (ifu).Potential causes for the reported unintended movement include, but are not limited to, extreme curves applied to the system, failing to re-lock the clip by advancing the lock lever or not following the steps outlined in the instructions for use.The discrepancy between what was reported vs what was noted during the return device analysis is likely due to user technique/procedural circumstances possibly resulting from the curves/tension on the device during preparation a review of the lot history record revealed no manufacturing nonconformities to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from the reported lot.All available information was investigated and a conclusive cause for the reported difficult to open or close and unintended movement could not be determined in this event.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11114297
• MDR Text Key: 225331262
• Report Number: 2024168-2021-00065
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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: 05/04/2021
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 00504U146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1