MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2017-04-20 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[73328890]
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. Zhang, michael, valentino, michael a.. Bilhemia: a rare complication of transjugular intraheptic portosytemic shunt. Acg case reports journal. 2015; 3(1):60-62
Patient Sequence No: 1, Text Type: N, H10
[73328891]
This information was received through case report? Bilhemia: a rare complication of transjugular intraheptic portosytemic shunt? Published in acg case reports journal, october 2015. The abstract reports a (b)(6) woman with cirrhosis due to (b)(6) underwent esophagogastroduodenoscopy for evaluation and banding of esophageal varices. During the procedure, a large varix ruptured, requiring an emergent tips procedure to control the hemorrhage using a 10 x 10 mm gore? Viatorr? Covered stent. Following tips, the patient experienced a rapid rise in serum bilirubin with no evidence of biliary obstruction or hepatic injury. She was determined to have bilhemia, a rare but serious complication of tips. Fifteen days after the tips procedure, an endoscopic retrograde cholangiopancreatography was performed to evaluate for evidence of a biliary-venous fistula. No evidence of a fistula or bile duct dilatation was found. A common bile duct stent was placed and sphincterotomy was performed in an attempt to lower the biliary pressure in order to reduce the flow of bile through a potentially unseen fistula. Despite this procedure, the patient? S bilirubin continued to rise, and a venogram to visualize and occlude the biliary-venous fistula was unremarkable. It was determined that the only viable way to reverse the bilhemia was through liver transplantation. During her hospital course, the patient developed a resistant klebsiella bacteremia. Even with appropriate treatment, she remained persistently bacteremic, possibly due to seeding of her tips. She developed sepsis complicated by renal failure and was transferred back to the intensive care unit. Unfortunately, the patient? S infection precluded her from undergoing liver transplantation and, after multiple discussions with the patient and her family, she was ultimately discharged home with hospice care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2017-00100 |
| MDR Report Key | 6508239 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-04-20 |
| Date of Report | 2017-03-24 |
| Date of Event | 2015-10-09 |
| Date Added to Maude | 2017-04-20 |
| 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 | 3 |
| Brand Name | GORE VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2017-04-20 |
| 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. Life Threatening; 2. Other | 2017-04-20 |