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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ABBOTT MITRACLIP XT
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ABBOTT ABBOTT MITRACLIP XT Back to Search Results
Lot Number 00718U219
Device Problems Mechanical Problem (1384); Misconnection (1399); Device Damaged by Another Device (2915)
Patient Problems Perforation of Vessels (2135); Multiple Organ Failure (3261); Valvular Insufficiency/ Regurgitation (4449)
Event Date 04/13/2021
Event Type  Death  
Event Description
During mitraclip procedure, device failed to lock inside the patient after implantation.Device had to be removed which led to damage to the existing mitral valve apparatus.Attempts made to place an additional clip unsuccessful.Due to damage to tissues and amount of regurgitation the patient was taken immediately to the operating room for a mitral valve repair.Patient expired on (b)(6) 2021 as a result of complications after surgery and multi-system organ failure.
 
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Brand Name
ABBOTT MITRACLIP XT
Type of Device
MITRACLIP XT
Manufacturer (Section D)
ABBOTT
3200 lakeside drive
santa clara CA 95054
MDR Report Key11783149
MDR Text Key249265462
Report Number11783149
Device Sequence Number1
Product Code NKM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/23/2021
Device Lot Number00718U219
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2021
Distributor Facility Aware Date04/13/2021
Event Location Hospital
Date Report to Manufacturer04/16/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/29/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Other;
Patient Age74 YR
Patient Weight89
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