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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
Model Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Thrombosis (2100)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
The device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is being filed to report thrombus. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4. At the beginning of the procedure, when inserting steerable guide catheter (sgc) thrombus was noted on the right atrial lead of the pacemaker. The procedure proceeded and during insertion, the thrombus was carried to the left atrium. A snare device tried to snare the thrombus and with a separate catheter, aspiration was performed. However, the thrombus had embolized. Neurology was consulted and the procedure continued. Two clips were implanted, reducing mr to 1. The procedure was finished with good results. After the procedure, the patient was woken up and followed all commands. There was no evidence of neurological defect. The patient was discharged. 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 Key10570254
MDR Text Key208084920
Report Number2024168-2020-07915
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/23/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00622U233
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 Received10/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2020
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: 09/22/2020 Patient Sequence Number: 1
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