MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional steerable guide catheter and a mitraclip devices referenced are filed under a separate medwatch report number.

Event Description

This is filed to report thrombus.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) (00213u315) was inserted, but after removing the dilator and super stiff wire, a 1cm thrombus was noticed floating in the sgc column.The sgc was removed and replaced with an additional sgc (00213u317).The sgc was inserted and no thrombus was noticed; therefore, the clip delivery system (cds) (00210u183) was inserted and advanced and positioned over the valve.However, at this moment, a 6mm thread like thrombus was confirmed to be attached to the tip of the clip.Transesophageal echocardiogram (tee) also showed that a 1mm thrombus was attached to the shaft of the sgc.It was noted that the activated clotting time (act) remained above 250 and below 350 throughout the entire procedure.The physician decided to administer agatroban to help treat the thrombus.This caused the thrombus to shrink and partly disappear; therefore, the procedure was continued.The clip was successfully implanted, reducing mr to a grade of less than 1.The thrombus remained in the anatomy, but a head angiography was then performed and showed that no embolism had occurred.After the procedure, it was noted that the patient was doing well and started taking aspirin.There was 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.The investigation was unable to determine a conclusive cause for the reported thrombosis.The reported patient effect of thrombosis, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10356405
• MDR Text Key: 202197077
• Report Number: 2024168-2020-06411
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 08/24/2020

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: 02/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00213U315
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other