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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENITI, INC. VENITI VICI VENOUS STENT; STENT, ILIAC

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VENITI, INC. VENITI VICI VENOUS STENT; STENT, ILIAC Back to Search Results
Model Number 90000014
Device Problems Collapse (1099); Fracture (1260)
Patient Problems Pain (1994); Swelling (2091)
Event Date 06/15/2015
Event Type  Injury  
Event Description
On (b)(6) 2015 the physician placed 3 overlapping venous stents in the patient for post thrombotic syndrome and occlusion.The stents were two 16mm x 120mm and one 16mm x 60mm.These stents were placed starting at the ivc and moving down the leg.The first stent placed was a 16mm x 120mm.The second stent was the other 16mm x 120mm stent.The third stent was the 16mm x 60mm stent.After the procedure, the patient remained symptomatic.On (b)(6) 2015, the physician performed an ivus and venogram which showed a fracture and compressed area in the second 16mm x 120mm stent, which had been overlapped with the first 16mm x 120mm stent and placed over the femoral head.The physician inserted another 16mm x 120mm covering the elongated/fractured part of the original 16mm x 120mm stent.The patient remained symptomatic.The patient had an appointment to see the physician again on (b)(6) 2015, but no report of that visit has been received.This event was reported to veniti on july 8, 2015.
 
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Brand Name
VENITI VICI VENOUS STENT
Type of Device
STENT, ILIAC
Manufacturer (Section D)
VENITI, INC.
des peres MO
Manufacturer Contact
daniel recinella
1610 des peres rd, ste 385
st louis, MO 63131
3142000255
MDR Report Key4961256
MDR Text Key6254601
Report Number3009865301-2015-00001
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/28/2015
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 Health Professional
Device Expiration Date04/01/2016
Device Model Number90000014
Device Catalogue NumberVEN16120
Device Lot Number14050160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/08/2015
Initial Date FDA Received07/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 YR
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