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

Model Number CDS0701-NTW

Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915)

Patient Problem Mitral Regurgitation (1964)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

The clip remains implanted.Investigation has not yet been completed.A follow-up report will be submitted with all additional relevant information.The second clip delivery system referenced is filed under a separate medwatch report number.

Event Description

It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The first clip delivery system (cds) (cds0701-ntw, 00723u172)) was advanced to the mitral valve and the clip was implanted successfully without issue.A second cds (cds0701-ntw, 00723u172) was advanced to further reduce mr.The cds was steered down and grasping was performed.However, the clip prematurely deployed, and remained attached to the gripper line and lock line.The clip was flailing with every heartbeat and came in contact with the first clip implanted causing a single leaflet device attachment (slda).The first clip detached from the anterior leaflet.The second cds with the inverted clip was able to be retrieved up to the steerable guide catheter (sgc) tip.The complete mitraclip system was pulled back to the groin area and a vascular surgeon was able to perform cut down procedure and remove the clip.The procedure was aborted with one clip implanted and mr at 4.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history did not identify a lot specific issue.Based on the information reviewed, the reported device damaged by another device was due to user technique/procedural conditions as the second clip interacted with this clip resulting in single leaflet device attachment (slda).The reported unchanged mitral regurgitation was a result of the reported incomplete coaptation.There is no indication of a product 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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11302737
• MDR Text Key: 240642640
• Report Number: 2024168-2021-01012
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: 03/08/2021

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: 07/23/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00723U172
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; STEERABLE GUIDE CATHETER
• Patient Age: 79 YR
• Patient Weight: 116