MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-26 for GORE VIATORR? TIPS ENDOPROSTHESIS PT107275 manufactured by W.l. Gore & Associates.
[50403443]
(b)(4). According to the gore viatorr tips endoprosthesis instruction for use (ifu) adverse events may include but are not limited to liver failure.
Patient Sequence No: 1, Text Type: N, H10
[50403444]
It was reported to gore the following: the patient presented with a portal hypertension which was intended to be treated with a gore viatorr tips endoprosthesis on (b)(6) 2016. The procedure was aborted due to multiple unsuccessful puncture attempts. On (b)(6) 2016 the patient underwent an additional implantation procedure with a gore viatorr tips endoprosthesis. The procedure was finalized successful. The final angiography showed a good flow and a good preserved perfusion of the portal vein branches in both hepatic lobes. Before implantation of the gore viatorr tips endoprosthesis the portal systemic pressure gradient showed 15 mm hg. After implantation of the gore viatorr tips endoprosthesis the gradient showed a reduction to 10mm hg. On (b)(6) 2016 the computed tomography of the abdomen showed a subtotal stenosis of a dorsal portal vein branch in the right hepatic lobe. Maybe caused by the covered stent portion and as well a small intraluminal thrombus in the proximal vessel section. Resultant in an irregular configured and hypodense liver infarction in segment vi and vii. The device is in the location as intended and without any signs of stenosis or occlusion. In addition the patient suffered from acute renal insufficiency and hyperkalemia. Laboratory parameters confirmed the liver infarction. On (b)(6) 2016 the patient was discharged a stable constitution.
Patient Sequence No: 1, Text Type: D, B5
[50630125]
(b)(6), lot 14051338, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007284313-2016-00134 |
| MDR Report Key | 5821279 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-26 |
| Date of Report | 2016-07-27 |
| Date of Event | 2016-05-30 |
| Device Manufacturer Date | 2015-07-07 |
| Date Added to Maude | 2016-07-26 |
| 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 | 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 | 2016-07-26 |
| Catalog Number | PT107275 |
| Lot Number | 14051338 |
| Device Expiration Date | 2018-07-06 |
| 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. Other | 2016-07-26 |