MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-XTR

Device Problems Unstable (1667); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

This is filed for clip opening.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 with a flail and dilated left atrium.A mitraclip xtr was advanced and the leaflets were grasped, however following clip arm inversion, it was noted that there was resistance felt while turning the arm positioner and it felt looser than normal.The clip was tested and closed to zero degrees.However, when the lock line was placed in the lock position, the clip arms then opened due to the arm positioner being over turned.The clip was safely closed and retracted back into the steerable guide catheter (sgc) and the undeployed clip and device were removed from the patient anatomy.Two mitraclips were successfully implanted, reducing mr to 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.It should be noted that the mitraclip ntr/xtr instructions for use, states ¿do not over invert the clip arms; stop turning the arm positioner when resistance is first noted.¿ 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.Based on the reported information a conclusive cause for the reported physical resistance / sticking of the arm positioner could not be determined.The reported improper or incorrect procedure or method is due to the user error of overturning the arm positioner.The unstable arm positioner and clip opening while locked were the result of user error.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9520470
• MDR Text Key: 178171551
• Report Number: 2024168-2019-14988
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90911U159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER