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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 06/17/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Based on the information reviewed, a conclusive cause for the thrombosis could not be determined. The reported patient effect of thrombosis is listed in the mitraclip system instructions for use (ifu), as a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This is being filed to report the thrombosis. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3. The steerable guide catheter (sgc) was inserted into the patient when thrombosis was visible at the puncture site in the left atrium (la). The procedure was continued with one clip implanted, reducing mr to 1+. The thrombosis was no longer visible at the end of the procedure. There was no clinically significant delay in the procedure and no adverse patient sequela.
 
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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 Key10253295
MDR Text Key198191842
Report Number2024168-2020-05604
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
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/30/2021
Device Catalogue NumberSGC0302
Device Lot Number00131U204
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 Received06/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2020
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: 07/09/2020 Patient Sequence Number: 1
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