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.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• 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: 10129079
• MDR Text Key: 194345392
• Report Number: 2024168-2020-04788
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• 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

• Device Expiration Date: 01/22/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00123U121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/08/2020 Patient Sequence Number: 1

Treatment

IMPLANTED MITRACLIP