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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 Problem Thrombosis (2100)
Event Date 11/02/2020
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation; 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 the thrombus. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. Five minutes after the steerable guide catheter (sgc) inserted into the groin, and the dilator and guide wire were retracted, while aspirating the sgc, a thrombus was noted at the hemostasis valve. The physician attempted to aspirate the thrombus but was unsuccessful the thrombus stayed in the hemostasis valve and was stable there but the risk to mobilize it was too high. Therefore, the sgc was removed and exchanged for a new sgc. After the first sgc was removed, there was no evidence of thrombus or something similar inside the patients heart or any other structure. The patient had heparin for bridging medication as an anticoagulation prior to the procedure. Activated clotting time (act) was 268 at the time when the thrombus was noted. One clip was implanted, reducing mr to 1-2. 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 Key10889479
MDR Text Key217926442
Report Number2024168-2020-09832
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 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/06/2021
Device Catalogue NumberSGC0302
Device Lot Number00806U204
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 Received12/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2020
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: 11/23/2020 Patient Sequence Number: 1
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