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

Model Number CDS0701-XTW

Device Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The steerable guide catheter (sgc) referenced is filed under mfr report number 2024168-2020-08814.

Event Description

This is filed for steering issues.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) of grade 4+.It was reported that during the procedure, the clip delivery system (cds) was noted to have steering issues device was noted to be mis-keyed.The steerable guide catheter (sgc) had flush port issues.The devices were removed without issue.A second sgc was then prepared and used, and one clip was implanted.Mr was reduced from grade 4+ to grade 1.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lhr and complaint history were not performed because no lot information was provided and the device was not returned for analysis.All available information was investigated and a cause for the reported activation, positioning or separation problem associated with the device being mis-keyed could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial mdr report, additional information was provided.During advancement, the clip delivery system (cds) and steerable guide catheter (sgc) were noted to be mis-keyed; however, no sleeve steering issue occurred.The devices were pulled back to key correctly.The alignment markers were noted to be aligned during insertion and removal of the devices.When the devices were pulled back to re-align, the flush port of the sgc was bumped, knocking it off.A second sgc was prepared and one clip was implanted.This event has been reported; therefore, it will remain reportable.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10750635
• MDR Text Key: 213696886
• Report Number: 2024168-2020-08989
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1