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

Catalog Number CDS0602-XTR

Device Problems Break (1069); Expulsion (2933); Material Deformation (2976); Mechanical Jam (2983)

Patient Problem Embolism (1829)

Event Date 01/14/2021

Event Type  Injury  

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 the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and the inability to remove the lock line/mechanical jam appears to be the result of the reported knot; however, a cause for how the knot formed could not be determined.The clip detaching from both the leaflets (expulsion), and lock line break appear to be related to user technique/procedural circumstances.Embolism is related to the procedural circumstances.Embolism is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The additional therapy/non-surgical treatment and foreign body removal were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report embolization and medical intervention it was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the mitral valve, and the first clip was deployed.Then a second clip delivery system (cds 01105u150) was advanced to the mitral valve, and the clip was placed.However, during the deployment sequence, the lock line became stuck.A decision was made to deploy the clip due to part of the gripper line had been inadvertently pulled into the handle of the delivery catheter, preventing the grippers from releasing the leaflets.There was an attempt to remove the cds over the lock line, but due to tension, the clip became fully detached from the valve.As the clip was still attached to the lock line, the clip was secured to the tip of the sgc.An attempt was made to retract the clip into the sgc when the lock line broke causing the clip to embolize into the mouth of the superior vena cava (svc).The clip was snared and withdrawn into the sgc.But then the sgc tip became torn.Therefore, after the sgc was removed, the procedure continued with a new sgc.It was noted a small knot was observed on the lock line after the embolized clip was removed.The new sgc was advanced to the mitral valve, and a third cds (00827u218) was advanced to the mitral valve; however, the clip could not grasp both leaflets.Therefore, the cds was removed with the clip attached.The procedure ended at this point.One clip was implanted, reducing mr to 3-4.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11286709
• MDR Text Key: 230511680
• Report Number: 2024168-2021-00907
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 01105U150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 81