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 2017-04-19 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[73222001]
(b)(6). A review of the manufacturing records for the device could not be conducted as item- and lot numbers of the device were not available. The article stated that the average of age was 58. 5 years, therefore 58 was used as age. As gender was chosen male, because the article stated m/f 261/128. Date of event: the date when the article was published was used as event date.
Patient Sequence No: 1, Text Type: N, H10
[73222002]
This information was received through the literature article:? Procedural and shunt-related complications and mortality of the transjugular intrahepatic portosystemic shunt (tipss)? Published ev pub online 27 september 2016 ap&t alimentary pharmacology and therapeutics. Bettinger d. , schultheiss m. , boettler t. , muljono m. , thimme r. , rossle m.. Procedural and shunt-related complications and mortality of the transjugular intrahepatic portosystemic shunt (tipss). Alimentary pharmacology and therapeutics. 2016; 44(10):1051-1061. This retrospective study (2004? 2014) included 389 patients in the study cohort. One hundred eighty four patients received a gore? Viatorr? Tips endoprosthesis and two hundred five patients a bare stent. During the index hospital stay, procedure-related complications occurred in 42 patients (10. 8%) with intraperitoneal bleeding in 8 patients (2. 1%) and infections in 14 patients (3. 6%). Shunt- and disease-related complicationsconsisted of hepatic encephalopathy in 113 patients (1-year incidence 29%), nonprocedural infections (8. 7%) and acute hepatic decompensation in 16 patients (4. 1%). Nine patients (2. 3%) died during the index hospital stay from procedure related (two patients, 0. 5%), shunt-related (four patients, 1%) or disease related causes (three patients, 0. 8%). 23 patients (5. 9%) died during 4 weeks after tipss implantation. The 1-year probability of survival was 67. 7% and was negatively associated with severe hepatic encephalopathyand acute hepatic decompensation. Specific reported complications for patients with a gore viatorr tips endoprosthesis include: hepatic encephalopathy - 44 (23. 9%); acute hepatic decompensation 9 (4. 9%); procedure related complications - 21 (11. 4%); infectious complications - 6 (3. 3%); other, including intra-abdominal bleeding, iatrogenic dissection of the inferior cava vein, biliovenous fistula, renal failure, pulmonary embolism, hypotonia and nausea and vomiting - 15 (8. 2%); index hospital mortality - 3 (1. 6%); 4-week mortality - 8 (4. 3%). There was no effect of the stent type on the development of post-tipss hepatic encephalopathy, acute hepatic decompensation and procedure-related complications. The conclusions for this study: except hepatic encephalopathy, severe procedure- and shunt-related complications are rare and early mortality is low.
Patient Sequence No: 1, Text Type: D, B5
[73280708]
Initial reporter: unknown was missed in the first report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007284313-2017-00097 |
| MDR Report Key | 6503436 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-19 |
| Date of Event | 2016-09-27 |
| Date Added to Maude | 2017-04-19 |
| 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 | 2017-04-19 |
| 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 | 2017-04-19 |