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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP MITRAL VALVE REPAIR DEVICES

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ABBOTT VASCULAR MITRACLIP MITRAL VALVE REPAIR DEVICES Back to Search Results
Model Number CDS0201
Event Date 10/23/2015
Event Type  Death  
Event Description

During delivery of 2nd mitraclip device, the clip became entangled in the left atrial appendage. Attempted release of the clip resulted in left atrial appendage laceration that required emergency open heart surgery. Manufacturer response for clip delivery system, mitraclip, clip delivery system, mitraclip (per site reporter): the vendor is aware of the incident as the rep is here for all cases.

 
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Brand NameMITRACLIP
Type of DeviceMITRAL VALVE REPAIR DEVICES
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591
MDR Report Key5243503
Report Number5243503
Device Sequence Number1
Product CodeNKM
Report Source User Facility
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberCDS0201
Device Catalogue NumberCDS0201
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2015
Device Age1 dy
Event Location Hospital
Date Report TO Manufacturer11/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/23/2015 Patient Sequence Number: 1
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