MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for GORE VIABIL? BILIARY ENDOPROSTHESIS (GI) manufactured by W.l. Gore & Associates.
[188412175]
Article: covered vs uncovered stents in malignant biliary obstruction from journal vascular interventional radiology 2020; 31:82-92. According to the instructions for use (ifu) for the gore? Viabil? Biliary endoprosthesis, complications may include those often associated with any endoscopic procedure performed on the biliary tract. These complications include: infection, bleeding, duct perforation, hematoma, hemobilia, cholangitis, pancreatitis, fever, trauma to ductal system or duodenum and death.
Patient Sequence No: 1, Text Type: N, H10
[188412176]
The following literature publication was reviewed: covered vs uncovered stents in malignant biliary obstruction. Per the article: the primary objective was to investigate whether the fully eptfe and fluorinated ethylene propylene (fep) covered stent would have at least a 25% lower occlusion rate compared with the reference bare self expandable metal stents (sem). The covered stent used was the gore? Viabil? Biliary endoprosthesis, an eptfe-pep coated nitinol stent with antimigration anchoring fins and no holes. After interim analysis, a 10 mm diameter version with similar lengths were used. Between may 2002 and october 2018, 496 patients with malignant biliary obstruction referred for percutaneous stent implantation after failed (endoscopic retrograde cholangiopancreatography) ercp were screened and 154 patients with an infrahilar occlusion were included in the study. The article reported the gore? Viabil? Biliary endoprosthesis was designed with an ultrathin eptfe-fep coating with low porosity to impede bacterial attachment. In the present trial, the device did not fulfill these expectations. The article reported major complications required an intervention, unplanned increase in level of care, or admittance to the intensive care unit, prolonging hospitalization or necessitating repeat hospitalization. The article reported complications in 5 patients with bleeding requiring an intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003910212-2020-00037 |
| MDR Report Key | 9887176 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-01 |
| Date of Event | 2019-07-07 |
| Date Added to Maude | 2020-03-26 |
| 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 | ANGELA BROWN |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MPD APC B/P |
| Manufacturer Street | P.O. BOX 1408 |
| Manufacturer City | ELKTON MD 219221408 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 219221408 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE VIABIL? BILIARY ENDOPROSTHESIS (GI) |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | FGE |
| Date Received | 2020-03-26 |
| 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. Hospitalization; 2. Other | 2020-03-26 |