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

Catalog Number CDS0602-XTR

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.

Event Description

This is filed to report foreign material.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The clip delivery system (cds) was advanced to the mitral valve and when the clip was opened for grasping, a thread was noted through echocardiogram just above the gripper.The physician decided to remove the cds and not deploy the clip.The cds was removed without any issue.Outside the patient anatomy, a long silver-white, thread a few centimeters long was retrieved.There was nothing noted on the clip and there was no damage to the clip cover.In the physician's opinion, there was nothing left in the patient anatomy.A new cds was used.One clip was implanted, reducing mr to 1-2.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis was unable to confirm the reported device contamination with chemical or other material.The discrepancy between what was reported (thread noted above the gripper) and what was observed (no contamination noted) may have been due to procedural circumstances (imaging, user interpretation etc.) or user related.All available information was investigated, and the reported device contamination with chemical or other material was not confirmed via returned device 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 other complaints reported from this lot.All information was investigated and based on information provided and the results of the returned device analysis, a conclusive cause for the reported device contamination with chemical or other material could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 10162887
• MDR Text Key: 195428092
• Report Number: 2024168-2020-05101
• 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: 07/17/2020

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: 01/06/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00106U229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1