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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR EVEROLIMUS ELUTING CORONARY STENT SYSTEM 3.5MMX8MM CORONARY DRUG-ELUTING STENT

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ABBOTT VASCULAR EVEROLIMUS ELUTING CORONARY STENT SYSTEM 3.5MMX8MM CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 8092841
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2019
Event Type  malfunction  
Event Description
Coronary stent deployed ostial right coronary artery and migrated up around guide catheter. Stent pulled back and relocated and deployed in right brachial artery. Fda safety report id # (b)(4).
 
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Brand NameEVEROLIMUS ELUTING CORONARY STENT SYSTEM 3.5MMX8MM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
ABBOTT VASCULAR
santa clara CA 95054
MDR Report Key8755362
MDR Text Key150123610
Report NumberMW5087767
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2019
Device Lot Number8092841
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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