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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 07/10/2020
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional steerable guide catheter and a mitraclip devices are filed under a separate medwatch report number.
 
Event Description
This is filed to report thrombus. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) (00213u315) was inserted, but after removing the dilator and super stiff wire, a 1cm thrombus was noticed floating in the sgc column. The sgc was removed and replaced with an additional sgc (00213u317). The sgc was inserted and no thrombus was noticed; therefore, the clip delivery system (cds) (00210u183) was inserted and advanced and positioned over the valve. However, at this moment, a 6mm thread like thrombus was confirmed to be attached to the tip of the clip. Transesophageal echocardiogram (tee) also showed that a 1mm thrombus was attached to the shaft of the sgc. It was noted that the activated clotting time (act) remained above 250 and below 350 throughout the entire procedure. The physician decided to administer agatroban to help treat the thrombus. This caused the thrombus to shrink and partly disappear; therefore, the procedure was continued. The clip was successfully implanted, reducing mr to a grade of < 1. The thrombus remained in the anatomy, but a head angiography was then performed and showed that no embolism had occurred. After the procedure, it was noted that the patient was doing well and started taking aspirin. 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 Key10356373
MDR Text Key202008884
Report Number2024168-2020-06410
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/11/2021
Device Catalogue NumberSGC0302
Device Lot Number00213U317
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 Received08/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2020
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: 08/03/2020 Patient Sequence Number: 1
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