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

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.

• 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 Key: 4961256
• MDR Text Key: 6254601
• Report Number: 3009865301-2015-00001
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• 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 Date: 04/01/2016
• Device Model Number: 90000014
• Device Catalogue Number: VEN16120
• Device Lot Number: 14050160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR