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

Model Number CDS0701-NTW

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.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 a leak, loose connection and material separation it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.One ntw clip was successfully implanted without issues.A second ntw clip (00928u327) was inserted into the steerable guide catheter (sgc).However, the physician noticed that the hub of the clip introducer (ci) did not come together with the back end of the sgc as securely as usual.This caused air to enter the sgc.The system was lowered below the patient heart and aspiration was performed, but the bubble in the sgc did not move.Since the bubble was immobile, the physician decided to continue with the procedure.The clip was successfully deployed, reducing mr to a grade of 1.However, after the clip delivery system (cds) was removed from the sgc, it was noticed that the soft portion of the ci had completely detached from the plastic port.No additional clips were implanted.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the reported issue of the material separation as the clip introducer (ci) tubing material was observed to be detached from the clip introducer housing and not bonded together.The reported leak/splash and loose or intermittent connection of the ci with the steerable guide catheter (sgc) could not be replicated in a testing environment due to the returned condition of the device (ci material separation).Additionally, it was noted that the non-tactile marker gripper lever cap and the latch were detached from the device.The investigation identified the loss of or failure to bond between the ci housing and the tubing and the ci material separation resulting in the reported leak and loose or intermittent connection as potential product issue.Additionally, the investigation determined the observed griper lever cap and latch separation as a potential product issue.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history identified no similar complaints from the lot.Based on the information reviewed and the analysis of the returned device, the investigation identified the loss of or failure to bond between the ci housing and the tubing and the ci material separation resulting in the reported leak and loose or intermittent connection and the observed non-tactile marker gripper lever cap and the latch separation as potential quality issues.The issues are being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• 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: 11208520
• MDR Text Key: 228015577
• Report Number: 2024168-2021-00580
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00928U327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER; IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 73