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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ABBOTT GRAFT MASTER CORONARY STENT
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ABBOTT ABBOTT GRAFT MASTER CORONARY STENT Back to Search Results
Catalog Number 1012580-19
Device Problem Partial Blockage (1065)
Patient Problem Thrombus (2101)
Event Date 03/23/2016
Event Type  Injury  
Event Description
The patient was in the cardiac cath lab for atherectomy of left main artery and lad and during the procedure the proximal lad was perforated and a graftmaster stent was deployed.This stent provided flow initially, sealing off the perforation.About 10 minutes after stent was deployed, the patient showed low blood pressure.A code blue was called, an echocardiogram performed and another angiogram was done which showed an in stent thrombosis.Integrilin was used and was able to dissolve the clot and, the stent was then patent.Ref mfr report #2024168-2016-02463.
 
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Brand Name
ABBOTT GRAFT MASTER CORONARY STENT
Type of Device
CORONARY STENT
Manufacturer (Section D)
ABBOTT
santa clara CA
MDR Report Key5587861
MDR Text Key43181277
Report Number5587861
Device Sequence Number1
Product Code MAF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2016
Device Catalogue Number1012580-19
Device Lot Number4100742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2016
Distributor Facility Aware Date03/24/2016
Event Location Hospital
Date Report to Manufacturer03/24/2016
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) Life Threatening;
Patient Age74 YR
Patient Weight61
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