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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Swelling/ Edema (4577)
Event Date 12/18/2023
Event Type  Injury  
Event Description
It was reported that the patient was admitted to the hospital approximately two weeks post implant.This eluvia drug-eluting vascular stent system was implanted in the right superficial femoral artery.Then approximately two weeks later, the patient presented with pain and swelling of the right leg; and a rash on the right leg which extended into the lower abdomen and lower back.The patient was admitted to the hospital and was started on steroid medications due to a suspected allergic reaction.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18539875
MDR Text Key333194155
Report Number2124215-2024-02580
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexMale
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