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 2017-04-17 for GORE VIATORR? TIPS ENDOPROSTHESIS PTB107275 manufactured by W.l. Gore & Associates.
[72939057]
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. Sakib, s m nazmus, kobayashi, katsuhiro, jawed, mohammed. Potential pitfalls in transjugular portosystemic shunt placement for bleeding rectal varices. Case reports in gastroenterology. 2015; 9:296-301.
Patient Sequence No: 1, Text Type: N, H10
[72939058]
This information was received through case report? Potential pitfalls in transjugular portosystemic shunt placement for bleeding rectal varices? Published in case reports of gastroenterology, 21 august 2015. The abstract reports a case of massive bleeding from large rectal varices in a (b)(6) man with alcoholic cirrhosis. Emergent transjugular intrahepatic portosystemic shunt (tips) placement was performed (10? 90 mm viatorr stent-graft) following failed local endoscopic therapy. Despite normalization of the portosystemic pressure gradient, the patient had another episode of massive bleeding on the following day. Embolization of the rectal varices via tips successfully stopped the bleeding. After the procedure, rapid decompensation of the cirrhosis led to severe encephalopathy. Despite maximal medical management, his clinical condition continued to deteriorate. He developed acute hypoxic respiratory failure secondary to multiple causes, including progressive liver failure. He required mechanical ventilation and became minimally responsive. Palliative care was instituted. He died 2 weeks after the tips placement.
Patient Sequence No: 1, Text Type: D, B5
[75106843]
Lot number 10786197: (b)(4). The articles states a 10? 90 mm viator stent-graft was implanted; however, the lot number provided by the author is a 10mm x 7cm device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007284313-2017-00091 |
| MDR Report Key | 6497972 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-04-17 |
| Date of Report | 2017-04-28 |
| Date of Event | 2015-08-21 |
| Device Manufacturer Date | 2012-10-08 |
| Date Added to Maude | 2017-04-17 |
| 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 | 2017-04-17 |
| Catalog Number | PTB107275 |
| Lot Number | 10786197 |
| Device Expiration Date | 2015-09-30 |
| 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. Death; 2. Other | 2017-04-17 |