MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0502

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported 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 and one clip delivery system referenced are filed under separate medwatch report numbers.

Event Description

This report is filed for difficulty removing the clip delivery system through the steerable guide catheter.It was reported that this was a mitraclip procedure treating mixed, functional and degenerative, mitral regurgitation grade 3 with a thin and immobile anterior medial leaflet due to a previous transcatheter aortic valve implantation.One mitraclip was implanted without reported issue.A second mitraclip (cds0602-xtr (b)(4)) was implanted; however, after 10 minutes this clip detached from the anterior medial leaflet and remains attached to the posterior medial leaflet (single leaflet device attachment -slda).Per physician, the slda was due to pre-existing anatomy.As treatment for the slda and to further reduce mr, it was decided to place a third mitraclip.The third clip, mitraclip (cds0502) was unable to grasp the leaflets due to anatomy.Reportedly, there was no evidence of tissue damage due to this difficulty grasping but it was decided to remove this device from the anatomy.During cds retraction and while retracting the clip introducer from the steerable gide catheter (sgc0302 (b)(4)), difficulty was encountered and the sgc flush port broke.A new sgc was used in replacement.A third mitraclip (cds0602-xtr) was implanted between the first and slda clip without reported issue.The mr was reduced to grade 2.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint device was not provided.All available information was investigated and a definitive cause for the reported difficulty to remove clip delivery system/steerable guide catheter could not be determined in this incident.Additionally, the reported failure to adhere or bond appears to be due to challenging patient anatomy (thin and immobile anterior medial leaflet).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7580419
• MDR Text Key: 110730757
• Report Number: 2024168-2018-04287
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

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 Catalogue Number: CDS0502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER2 IMPLANTED MITRACLIPS