MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[44336542]
Lopera je, speeg kv, young c, et al. Segmental liver ischemia / infarction after elective transjugular intrahepatic portosystemic shunt creation: clinical outcomes in 10 patients. Journal of vascular & interventional radiology 2015;26(6):835-841. No additional information was provided by the author.
Patient Sequence No: 1, Text Type: N, H10
[44336543]
This information was received through literature article " segmental liver ischemia / infarction after elective transjugular intrahepatic portosystemic shunt creation: clinical outcomes in 10 patients" published in journal of vascular & interventional radiology, 2015. This article is a retrospective review of 10 patients who underwent elective tips creation between march 2006 and september 2014. Nine of the 10 patients received a gore viatorr tips endoprosthesis, and one patient received a wallstent device. The article does not clarify which patients received viatorr devices. The article reports "a patient who had received a liver transplant and had a large 40% liver infarct with associated thrombosis of the anterior branch of the right pv and middle and left hepatic veins developed a large area of necrosis, with subsequent biloma formation that required complex drainage interventions. " "this patient presented with fever and abdominal pain 10 days after the tips procedure. After percutaneous drainage of the collection, a large fistula with communication with the right biliary system was noted. The biliary fistula was finally controlled after embolization with coils and placement of a plastic biliary stent in the distal common bile duct. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2016-00433 |
| MDR Report Key | 5625631 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-08 |
| Date of Event | 2015-06-01 |
| Date Added to Maude | 2016-05-03 |
| 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 ECHO RIDGE B/P |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| 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 | 2016-05-03 |
| 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. Required No Informationntervention | 2016-05-03 |