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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Embolism (1829); Thrombosis (2100); Visual Disturbances (2140)
Event Date 03/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report thrombosis/stroke. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. During the procedure, thrombus was noted on the tip of the steerable guide catheter (sgc). Two clips were implanted on the without issue, reducing the mr to 1. Approximately 3 1/2 hours post procedure the patient suffered a stroke resulting in hemiparesis and hemianopsia. The stroke is reported to be due to thrombus formation on the sgc, in spite of an activated clotting time of >300. The patient is still experiencing hemianopsia (visibility issues), but is reported to be getting better. No treatment was performed as the patient was already on anticoagulants pre-interventionally. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key7409574
MDR Text Key104777048
Report Number2024168-2018-02584
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/25/2018
Device Catalogue NumberSGC0302
Device Lot Number70925U141
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 Received06/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2017
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: 04/09/2018 Patient Sequence Number: 1
Treatment
TWO (2) IMPLANTED MITRACLIPS
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