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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 Physical Resistance (2578)
Patient Problems Cardiac Arrest (1762); Thrombosis (2100); Ventricular Tachycardia (2132); Cardiac Tamponade (2226)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Internal file number - (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 additional relevant information.
 
Event Description
This is filed to report the cardiac arrest requiring cardiopulmonary resuscitation (cpr) and the thrombus. It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr) with a grade of 4. The patient presented with atrial fibrillation (af). After introduction of anesthesia the heart rate increased, but continued in af. The steerable guide catheter (sgc) was advanced into the anatomy and difficulty was noted crossing the septum into the left atrium (la). After removal of the dilator, the patient went into ventricular tachycardia (vt) and cardiac arrest, requiring cpr. The rhythm continued to waver between fast af and vt and cpr was continued. After the patient stabilized, thrombosis was seen on the tip of the guide in the left atrium. This resolved with time and activated clotting time (act) management. Two clips were successfully implanted, reducing mr to grade 1. After the procedure, the patient may have experienced cardiac tamponade, but this could not be confirmed and no treatment was provided. There was no additional information provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no similar incidents reported from this lot. The reported patient effects of cardiac arrest, thrombosis, and ventricular tachycardia, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. All available information was investigated and the reported physical resistance appears to be related to user technique (high tenting). The reported cardiac arrest and ventricular tachycardia was due to procedural conditions (adrenal failure). A definitive cause for the reported thrombus could not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial 30-day medwatch report, the following information was received: the cardiac tamponade did not occur. There was no additional information 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 Key7604147
MDR Text Key111142691
Report Number2024168-2018-04496
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/07/2019
Device Catalogue NumberSGC0302
Device Lot Number80306U222
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 Received08/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2018
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: 06/14/2018 Patient Sequence Number: 1
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