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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2018
Event Type  Injury  
Manufacturer Narrative
Device is a combination device.
 
Event Description
It was reported that in-stent thrombus occurred.An eluviatm drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).It was noted that in-stent thrombus occurred on the same day.The patient was required to have a re-intervention; thrombectomy and ballooning.The outcome of the procedure was good.There were no patient complications and the patient's status is stable.
 
Event Description
It was reported that in-stent thrombus occurred.An eluviatm drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).It was noted that in-stent thrombus occurred on the same day.The patient was required to have a re-intervention; thrombectomy and ballooning.The outcome of the procedure was good.There were no patient complications and the patient's status is stable.
 
Manufacturer Narrative
Corrected fields: patient codes, device codes.Device is a combination device.
 
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Brand Name
ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8254786
MDR Text Key133283280
Report Number2134265-2019-00087
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/26/2018
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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