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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MITRACLIP
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ABBOTT MITRACLIP Back to Search Results
Model Number CDS0601-XTR
Device Problems Mechanical Problem (1384); Mechanical Jam (2983); Firing Problem (4011)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 07/03/2019
Event Type  Death  
Event Description
An (b)(6) y/o male with a history of multiple co-morbidities presented to (b)(6) for percutaneous mitral valve repair with mitraclip placement.The first mitraclip and delivery system was prepped with pressurized heparinized normal saline and was successfully deployed.The second mitraclip was prepped using the remaining fluids and add'l fluids were hung.During the deployment of the second clip the pt was noted to have a decrease in his oxygen saturation.Anesthesia noted the pt was progressively hypotensive and bradycardic with significant air noted in the lv.The pt went into cardiac arrest and cpr was initiated.Despite resuscitative measures the pt expired.
 
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Brand Name
MITRACLIP
Type of Device
MITRACLIP
Manufacturer (Section D)
ABBOTT
3200 lakeside dr.
santa clara CA 95054
MDR Report Key8836667
MDR Text Key152551482
Report Number8836667
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2020
Device Model NumberCDS0601-XTR
Device Catalogue NumberCDS0601-XTR
Device Lot Number90301U225
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2019
Distributor Facility Aware Date07/03/2019
Event Location Hospital
Date Report to Manufacturer07/19/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/19/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Death;
Patient Weight92
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