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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 CDS0601-XTR
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Death (1802); Occlusion (1984); Ventricular Tachycardia (2132)
Event Date 07/22/2020
Event Type  Death  
Event Description
Patient was in heart failure with afib rvr and was evaluated for consideration for mitraclip.Updated echocardiogram found severe mitral valve regurgitation with flail leaflet.The patient underwent placement of two mitraclips with reduction in mitral valve regurgitation.Two days later, the patient had a stemi, and upon verifying that family wanted intervention given dnr code status, the patient was taken urgently to the cath lab where angiogram revealed embolized mitraclip occluding the right coronary artery.The clip was able to be dislodged however the patient experienced multiple episodes of v-tach and despite all critical care interventions, he did not survive.
 
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Brand Name
MITRACLIP
Type of Device
MITRAL VALVE REPAIR DEVICES
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez rd
temecula CA 92591
MDR Report Key10778438
MDR Text Key214363031
Report Number10778438
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/25/2020,09/24/2020
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? No
Device Operator No Information
Device Model NumberCDS0601-XTR
Device Catalogue NumberCDS0601-XTR
Device Lot Number00117U159/ 00222U119/ 00117U15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/25/2020
Event Location Hospital
Date Report to Manufacturer11/03/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age30660 DA
Patient Weight78
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