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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
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.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE 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 Key10129079
MDR Text Key194345392
Report Number2024168-2020-04788
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161985
Number of Events Reported1
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 Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/22/2021
Device Catalogue NumberSGC0302
Device Lot Number00123U121
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 Received06/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2020
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
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