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

Catalog Number CDS0602-XTR

Device Problems Unstable (1667); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.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 clip open inability and inability to remove lock line.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 2-3.During preparation, the clip delivery system (cds) the clip could not be opened.Troubleshooting was performed and the clip was able to be opened to 120 degrees.The cds was advanced to the mitral valve and the clip was placed.During an attempt to deploy the clip, resistance was noted during removal of the lock line and the lock line could not be removed; therefore, this clip was not deployed.A new cds was advanced and the clip was deployed.One clip was implanted, and the mr was reduced to <1.It was noted that the arm positioner was different in handling and felt loose during the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported lock line jam, unstable arm positioner, and inability to open clip were confirmed via returned device analysis.Analysis additionally identified gripper line jam, scratched interior arm positioner rails, delivery catheter handle bond break and dowel pin derailment.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 did not indicate a lot-specific issue.Based on the information provided and the returned device analysis, the reported unstable arm positioner and inability to open clip are the result of the dowel pin derailment.The observed scratched interior arm position rails are the result of the dowel pin derailment.A conclusive cause for the reported dowel pin derailment cannot be determined.A conclusive cause for the reported lock line and gripper line jam cannot be determined.The observed delivery catheter block bond failure appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10374903
• MDR Text Key: 202050990
• Report Number: 2024168-2020-06582
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 91113U337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER