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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 Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 02/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of the event is unknown, the first date of the month of the aware date was used.
 
Event Description
It was reported that the stent was fractured.An eluvia self-expanding stent system was implanted.Approximately three years later, the patient presented with leg pain and imaging was done.A stent fracture was apparent in the imaging and some calcification was noted at the point of fracture.A second procedure was not yet performed.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9738849
MDR Text Key180625379
Report Number2134265-2020-01865
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2020
Initial Date FDA Received02/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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