MAUDE Adverse Event Report: VENITI, INC. VICI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Swelling (2091)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event.The event date was not provided.The first date of the month of the aware date was selected.

Event Description

It was reported that the patient experienced pain, swelling, inflammation and an allergic reaction.A vici iliac stent was implanted.Immediately following the implantation, the patient had an onset of increased pain.The pain was severe cramping in the pelvic area.It was noted that there was swelling and inflammation around the stent itself.Plavix was prescribed.A couple of weeks after the stent was implanted, the patient developed a terrible rash over the entire body.The patient discontinued the use of plavix and was given huge doses of steroids.The steroids made the rash go away.Rough skin was noted where the rash used to be.Multiple doses of steroids have been given to the patient since the rash went away.The patient experiences terrible pelvic cramping similar to labor pains, unless anti-inflammatory medications are taken.The patient is generally tired, has no energy and basically just feels terrible.None of these symptoms were present prior to the stent being implanted.The patient presented with leg pain; however the stent itself did not fix the leg pain, in fact it just became worse after the stent was implanted.The patient was tested to determine the source of the reactions, and the patient was found to be reactive or hypersensitive to titanium.Further testing was requested by the patient to determine if the reactions are related to the stent material.

Manufacturer Narrative

B3: date of event.The event date was not provided.The first date of the month of the aware date was selected.

Event Description

This event was further reported via a voluntary medwatch #mw5092575.It was reported that the patient experienced pain, swelling, inflammation and an allergic reaction.A vici iliac stent was implanted.Immediately following the implantation, the patient had an onset of increased pain.The pain was severe cramping in the pelvic area.It was noted that there was swelling and inflammation around the stent itself.Plavix was prescribed.A couple of weeks after the stent was implanted, the patient developed a terrible rash over the entire body.The patient discontinued the use of plavix and was given huge doses of steroids.The steroids made the rash go away.Rough skin was noted where the rash used to be.Multiple doses of steroids have been given to the patient since the rash went away.The patient experiences terrible pelvic cramping similar to labor pains, unless anti-inflammatory medications are taken.The patient is generally tired, has no energy and basically just feels terrible.None of these symptoms were present prior to the stent being implanted.The patient presented with leg pain; however the stent itself did not fix the leg pain, in fact it just became worse after the stent was implanted.The patient was tested to determine the source of the reactions, and the patient was found to be reactive or hypersensitive to titanium.Further testing was requested by the patient to determine if the reactions are related to the stent material.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 9643615
• MDR Text Key: 177048231
• Report Number: 2134265-2020-00626
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: QAN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR