MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[72986934]
A device lot number was not provided; therefore, an investigation was unable to be performed and a cause of the reported event was unable to be determined. Green, michael s. , ahmed, brittany, bourm, kelsey, coffey, charles, salyers, william. Septic thrombus of a transjugular intrahepatic portosystemic shunt (tips) resulting in psoas muscle abscess: a case report of endotipsitis. American journal of gastroenterology. 2016; 111:s897 issn: 15720241.
Patient Sequence No: 1, Text Type: N, H10
[72987015]
This information was received through abstract "septic thrombus of a transjugular intrahepatic portosystemic shunt (tips) resulting in psoas muscle abscess: a case report of endotipsitis" published in the american journal of gastroenterology, 2016. The abstract presents a case of an infected tips thrombosis that extended through the inferior vena cava (ivc) into the right atrium and resulted in right psoas muscle abscess. The abstract states "an (b)(6) male with a history of cryptogenic cirrhosis requiring tips for diuretic resistant ascites who had suffered a complicated course involving multiple in-stent stenosis necessitating repeat tips and revision presented to an outside facility ed with increasing abdominal girth and back discomfort two weeks after undergoing a second revision with successful placement of a viatorr stent. A contrast-enhanced computed tomography (ct) scan of the abdomen appeared to display contrast within the second tips and no other abnormalities. Although at this time no doppler study was performed and the patient was discharged to home. Three days later the patient returned with worsening back pain. At that time, contrast-enhanced ct revealed an occluding thrombus extending from the origin of the main portal vein to the right atrium, along with scattered thrombi in the infrarenal ivc. A new fluid collection was also seen in the left psoas. Drainage of the psoas abscess was performed. Two blood cultures and abscess fluid culture grew staphylococcus hominis. The patient was transferred to a facility equipped for complex endovascular procedures and underwent an ir-guided thrombolysis of the ivc thrombus with tips revision. The patient subsequently improved and was discharged home with subcutaneous enoxaparin for anticoagulation and four weeks of iv ceftriaxone for bacteremia. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2017-00092 |
| MDR Report Key | 6498793 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-03-24 |
| Date of Event | 2016-10-01 |
| Date Added to Maude | 2017-04-17 |
| 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 | MARCI STEWART |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | FLAGSTAFF AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL PHOENIX 1 B/P |
| Manufacturer Street | 32360 N. NORTH VALLEY PARKWAY |
| Manufacturer City | PHOENIX AZ 85085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GORE VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2017-04-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-04-17 |