MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[136549307]
(b)(4). Literature citation: klinger c, riecken b, m? Ller j, westphal a, l? Ffler j, froehlich e, caca k. 2018. Doppler ultrasound surveillance of tips-patency in the era of covered stents? Retrospective analysis of a large single-center cohort. 2018. Z gastroenterol; 7: 1053-1062. Doi: 10. 1055/s-0044-102107. The gore? Viatorr? Tips endoprosthesis instructions for use note that adverse events may include prosthesis malposition, prosthesis/device failure, thrombosis, stenosis, occlusion, and/or death.
Patient Sequence No: 1, Text Type: N, H10
[136549308]
This information was received through literature article "doppler ultrasounds surveillance of tips-patency in the era of covered stents - retrospective analysis of a large single-center cohort" published online in zeitschrift f? R gastroenterologie, (b)(6) 2018. The purpose of this single-center retrospective study was to determine accuracy and necessity of long-term doppler ultrasound (du) surveillance of transjugular intrahepatic portosystemic shunt (tips) patency after implantation of an eptfe-covered stent graft (gore? Viatorr? Tips endoprosthesis). The study includes 228 consecutive cirrhotic patients with tips implantation (january 2007 to june 2014) due to portal hypertensive complications. Standardized du surveillance was scheduled 3-5 days, 3 months, and 6 months after tips implantation and every 6 months thereafter. Portal venography was performed in cases of du findings suspicious of tips dysfunction, clinical signs of recurrent portal hypertension, or refractory hepatic encephalopathy. The article reports that a patient with clinical suspicion of tips dysfunction died shortly after admission prior to du/angiography.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2019-00047 |
| MDR Report Key | 8351935 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-09-17 |
| Date Added to Maude | 2019-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2019-02-19 |
| 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. Death | 2019-02-19 |