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.
[72985694]
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. Mocharla, robert, khanna, lauren. An unusual case of transjugular intrahepatic portosystemic shunt (tips) causing biliary obstruction. American journal of gastroenterology. 2016; 111:s539 issn: 15720241.
Patient Sequence No: 1, Text Type: N, H10
[72985695]
This information was received through abstract "an unusual case of transjugular intrahepatic portosystemic shunt (tips) causing biliary obstruction" published in the american journal of gastroenterology, 2016. The abstract reports: a (b)(6) female with cryptogenic cirrhosis was referred by her hepatologist to our emergency department. Her history was notable for refractory hepatic hydrothorax, for which she had received a transjugular intrahepatic portosystemic shunt (tips) 1 month prior. Her tips consisted of a 10mm x 7cm viatorr stent and a 10mm x 4cm smart stent (2. 5cm overlap), from the main portal vein to left hepatic vein. On evaluation in the emergency department, her total bilirubin was 22. 5 mg/dl, up from 19. 1 mg/dl on discharge after tips. Mrcp showed left? Sided intrahepatic biliary ductal dilation proximal to the tips with no right-sided biliary ductal dilation. Ercp revealed a mildly dilated left main hepatic duct and moderately dilated left intrahepatic branches, with a transition point at the tips stent. A 9 mm balloon could be pulled through the area of extrinsic compression with minimal resistance. A 7 french x 15cm double pigtail plastic biliary stent was placed in the left intrahepatic bile duct. After stent placement, her total bilirubin decreased to 13. 8 mg/dl the following day, and to 10. 5 mg/dl the day of discharge. Our patient developed biliary obstruction due to tips stent compression of her left hepatic biliary tree. Our case highlights a rare complication from a tips, and demonstrates that this can be successfully treated with biliary stenting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2017-00093 |
| MDR Report Key | 6498859 |
| 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. Required No Informationntervention | 2017-04-17 |