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

Model Number CDS0701-NTW

Device Problems Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed for clip unable to open and clip jumping open.It was reported that this was a mitraclip procedure to functional mitral regurgitation (mr) of grade 4.Patient anatomy included a calcified annulus.The first clip (00912u154) was prepared for use and no issues were noted.The clip was advanced without issue; however, in the patient anatomy, it was noted that the grippers would not lower.Simultaneous and independent were tried, but neither gripper would lower.The clip was removed without issue and a second clip was then used.The second clip (00921u179) was prepared for use and no issues were noted.The clip was advanced into the patient anatomy and the clip was able to grasp the leaflet.However, due to the calcified annulus, the decision was made to release the clip to attempt a better grasp.The physician raised the grippers and unlocked the clip, but it was thought that the clip didnt unlock all the way.The physician was asked to close the clip first; however, the clip was unlocked without closing first.The clip sprung open and got caught in the chords.Troubleshooting maneuvers were performed to remove the clip from the chordae and the clip was able to be removed from the chords without tissue damage.Two additional clips were used and implanted without issue, reducing mr to grade 2.There were no adverse patient effects 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 lot history identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not identify any similar incidents.The reported difficult or delayed positioning (anatomy) was due to procedural conditions as the clip got caught in the chords.A cause for the reported clip jumpiness could not be determined.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: 11423510
• MDR Text Key: 240650720
• Report Number: 2024168-2021-01752
• 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: 04/29/2021

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: 09/21/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00921U179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 72