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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR INC. MITRACLIP; MITRAL VALVE REPAIR DEVICES
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ABBOTT VASCULAR INC. MITRACLIP; MITRAL VALVE REPAIR DEVICES Back to Search Results
Model Number CDS0701-NT
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Event Description
During a mitraclip procedure, the clip became dislodged from the delivery spear.The clip remained tethered to the delivery device and was retracted to the distal end of the delivery device.The clip and delivery device were safely withdrawn to the right iliac vein.The vascular or team came to the cath lab and surgically removed the clip and delivery system from the right iliac vein.
 
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Brand Name
MITRACLIP
Type of Device
MITRAL VALVE REPAIR DEVICES
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez road
temecula CA 92591
MDR Report Key11300932
MDR Text Key230954646
Report Number11300932
Device Sequence Number1
Product Code NKM
UDI-Device Identifier08717648230943
UDI-Public(01)08717648230943
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCDS0701-NT
Device Catalogue NumberCDS0701-NT
Device Lot Number00730U192
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2021
Event Location Hospital
Date Report to Manufacturer02/09/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age28835 DA
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