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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 Problem Thrombosis (2100)
Event Date 06/11/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Based on the available information, a definitive cause for the reported thrombosis could not be determined. The reported patient effect of thrombosis is listed in the mitraclip system instructions for use as known as possible complications associated with mitraclip procedures. A conclusive cause for the reported patient effects, and the relationship to the device, if any, cannot be determined. There is no indication of a product issue with respect to manufacture, design, or labeling.
 
Event Description
This is being filed to report the thrombus. During use with the steerable guide catheter. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. The steerable guide catheter (sgc) was advanced across the septum and a small thrombus was noted at the tip of the sgc. Activated clotting time (act) was therapeutic at 294. The physician aggressively aspirated the thrombus successfully. Medication (heparin) was given to the patient. The procedure was continued without any complications. One clip was implanted, reducing mr to 2. The patient was reported to be doing well and 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 Key10190296
MDR Text Key196273678
Report Number2024168-2020-05304
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
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/26/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number91226U131
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 Received06/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2019
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: 06/24/2020 Patient Sequence Number: 1
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