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.
[73230949]
(b)(6). (b)(4). Date of event: the date when the article was published was used as event date.
Patient Sequence No: 1, Text Type: N, H10
[73230950]
This information was received through literature article? Endovascular removal of the viatorr stent-grafts. Report of two cases? Published: 22 may 2015 in polish journal of radiology. Cwikiel, wojciech, bergenfeldt, magnus, keussen, inger. Endovascular removal of the viatorr stent-grafts. Report of two cases. Polish journal of radiology. 2015; 80:277-80 issn: 1733-134x, 1733-134x (issnlinking). Second case: the article stated that a (b)(6) male with alcohol-related cirrhosis, ascites and bleeding from the varices was referred for gore? Viatorr? Tips endoprosthesis to the department of endovascular surgery of a nearby hospital. Co2 portography was performed in there through a balloon catheter placed in the branch of the middle hepatic vein, showing patent pv. During transjugular, transhepatic attempt to puncture pv, a bile duct was accidentally entered (figure 3). That was misinterpreted by the physician performing the procedure, who placed a viatorr connecting the bile duct to the right hepatic vein. The physician reported later that? The flow from the smv was good, the gradient was=0 mmhg, and the tips was created successfully?. On the following three days the patient? S condition deteriorated and on the fourth day he showed signs of general sepsis and abdominal distension requiring urgent icu care. The inflammatory parameters were high and the laboratory tests were critically elevated (p-bilirubin=466? Mol/l;crp=43 mg/l; p-creatinine=435? Mol/l). At that time the error was identified and a percutaneous biliary drainage catheter was placed percutaneously through the right liver lobe bile ducts to the duodenum. Afterwards, the patient was transferred to the department of hepatic surgery for urgent treatment. The first viatorr was removed and a second viatorr was placed successful. Co2 portography confirmed good flow through the tips channel and no flow to the bile duct. In the following three weeks, the patient recovered substantially and the laboratory test results normalized.
Patient Sequence No: 1, Text Type: D, B5
[74292206]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007284313-2017-00098 |
| MDR Report Key | 6506952 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-25 |
| Date of Event | 2015-05-22 |
| 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 | RUTH KUNZMANN |
| 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 Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-04-20 |