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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 Unintended Movement (3026)
Patient Problems Tachycardia (2095); Cardiac Tamponade (2226); Atrial Perforation (2511); Pericardial Effusion (3271)
Event Date 11/20/2020
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 that would have contributed to the reported event. Additionally, a review of the complaint history identified no other incidents reported from this lot. Based on the available information, a cause for the unintended movement could not be determined. The reported pericardial effusion appears to have been a result of procedural conditions. The cardiac tamponade and tachycardia appear to have been cascading events of the pericardial effusion. The reported patient effects of pericardial effusion, cardiac tamponade, and tachycardia are listed in the mitraclip system instructions for use and are known possible complications associated with mitraclip procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is being filed to report the pericardial effusion requiring intervention. 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 placed in the left atrium (la) when the clip introducer of the clip delivery system (cds) was inserted into the hemostatic valve of the sgc. The tip of the sgc moved forward and injured the lateral wall, causing a pericardial effusion. The patients heart rate increased and blood pressure dropped. The patient was hemodynamically stabilized and the effusion punctured. The procedure was continued with one clip implanted, reducing mr to 1-2. The patient was hospitalized for further monitoring. 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 Key11012755
MDR Text Key221839901
Report Number2024168-2020-10523
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/05/2021
Device Catalogue NumberSGC0302
Device Lot Number00604U205
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 Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2020
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: 12/15/2020 Patient Sequence Number: 1
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