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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE¿; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE¿; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941224400
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem No Code Available (3191)
Event Date 11/04/2019
Event Type  malfunction  
Event Description
At catheterization the mid right coronary artery was found to have a 100% calcified, thrombotic occlusion.Successful intervention with serial dilatation and mechanical thrombectomy resulted in thrombolysis in myocardial infarction (timi)-3 flow.An attempt was then made to advance a drug-eluting stent.However, the stent appeared to be stripping off the balloon within the proximal right coronary artery.When an attempt was made to retract the stent into the guide catheter, it became crimped against the edge of the guide catheter opening.While attempting to remove the coronary guide catheter and stent with balloon system as a unit, the stent stripped off the balloon within the radial artery distal to the elbow joint.
 
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Brand Name
PROMUS ELITE¿
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9382596
MDR Text Key168220104
Report Number9382596
Device Sequence Number1
Product Code NIQ
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 11/21/2019,11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH7493941224400
Device Catalogue NumberH7493941224400
Device Lot Number22559117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2019
Event Location Hospital
Date Report to Manufacturer11/27/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/27/2019
Type of Device Usage N
Patient Sequence Number1
Patient Age1825 DA
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