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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC VICI STENT; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC VICI STENT; STENT, ILIAC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Autoimmune Reaction (1733); Pain (1994); Cramp(s) (2193)
Event Date 08/02/2019
Event Type  Injury  
Event Description
I had a boston scientific vici stent placed in my left iliac vein and have had severe pain and cramping that have been unable to resolved since.The stent was placed for what was thought to be mays thurner but it did not resolve my leg issue and instead gave me terrible pelvic cramping and back pain that continues.All medical tests have been exhausted to determine the cause.I was assured by the doctor that the material of the stent is a nerd and that it is unreasonable to consider sensitivity to the material.I have autoimmune disorders which make me susceptible for reactivity.There should really be required testing or warnings for all patients that are going to receive the "stance".I also was not informed that the stent could not be removed without being life-threatening.They should be required.Fda safety report id # (b)(4).
 
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Brand Name
BOSTON SCIENTIFIC VICI STENT
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key9641605
MDR Text Key177139763
Report NumberMW5092575
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/28/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age56 YR
Patient Weight59
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