MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-29 for VICI manufactured by Veniti, Inc..
[177048231]
Date of event. The event date was not provided. The first date of the month of the aware date was selected.
Patient Sequence No: 1, Text Type: N, H10
[177048232]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00626 |
| MDR Report Key | 9643615 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | VENITI, INC. |
| Manufacturer Street | 4025 CLIPPER COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICI |
| Product Code | QAN |
| Date Received | 2020-01-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENITI, INC. |
| Manufacturer Address | 4025 CLIPPER COURT FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-29 |