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

Catalog Number CDS0705-XTW

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This will be filed to report the information on inner box label is not correct.It was reported that when unpacking of the xtw clip delivery system (cds), it was noted that the device was in an nt box.The box was marked as an nt cds; however, the label showed xtw and the device inside was an xtw.The physician continued the procedure with the xtw cds, the clip was implanted to treat functional mitral regurgitation (mr), reducing mr from 4 to 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 lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The reported marking/labeling problem (box was marked as an nt clip delivery system and the label showed xtw) appears to be related to a potential product issue.The issue is 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: 12246250
• MDR Text Key: 264089375
• Report Number: 2024168-2021-06634
• 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
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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: 11/03/2021
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 01103U101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER