MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[113281869]
Literature article citation: verbeeck sarah, mekhali djalila, cassiman david, maleux geert, witters peter. Long-term outcome of transjugular intrahepatic portosystemic shunt for portal hypertension in autosomal recessive polycystic kidney disease. Digestive and liver disease https://doi. Org/10. 1016/j. Dld. 2018. 03. 009.
Patient Sequence No: 1, Text Type: N, H10
[113281890]
The following event was reported in the literature article "long-term outcome of transjugular intrahepatic portosystemic shunt for portal hypertension in autosomal recessive polycystic kidney disease. " the study reported on 5 children with chr treated with a tipss to manage severe portal hypertension related symptoms. It was reported 4 of the 5 patients received a gore? Viatorr? Tips endoprosthesis. It was reported this patient had in-stent stenosis. It was also reported this patient needed a liver transplantation 15 years after the tips procedure. In the months before transplantation she suffered from recurrent cholangitis with sepsis and acute respiratory distress syndrome. Radiographic imaging (ultrasound, ct and pet-ct scan) showed the development of multiple small liver abscesses. Due to the severity of the infections and the fact that endotipsitis could not be excluded, she was placed on the transplant list and received a liver transplantation two months later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00195 |
| MDR Report Key | 7665485 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-03-07 |
| Date Added to Maude | 2018-07-05 |
| 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 | ASHLEY MAROSTICA |
| 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 | 3 |
| Brand Name | GORE VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2018-07-05 |
| 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 | 2018-07-05 |