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 Problems Embolism (1829); Thrombosis (2100)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

The location of the reported device was not provided; however, when information is received the investigation will be completed.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report thrombus.It was reported that this was a mitra clip procedure to treat functional mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted; however, the physician observed thrombus near the steerable guide catheter (sgc) on the right side of heart.It was noted that the activating clotting time (act) remained between 250 and 300 throughout the procedure.In an attempt to treat the thrombus, additional heparin was administered; however, the thrombus was unable to be treat.Therefore, the sgc was removed and the thrombus remained on the right side of the heart.No additional clips were implanted, and mr was reduced to a grade of 1.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.Based on the information provided a conclusive cause for the reported thrombosis cannot be determined.The reported embolism is the result of the thrombosis.The reported patient effect of thrombosis and embolism, as listed in the mitraclip system instructions for use, are known possible complications 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: 10129079
• MDR Text Key: 194345392
• Report Number: 2024168-2020-04788
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00123U121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention