MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-22 for GORE VIATORR? TIPS ENDOPROSTHESIS PT108275 manufactured by W.l. Gore & Associates.
[75602636]
(b)(4). The review of the manufacturing and sterilization paperwork verified that this lot met all pre-release specifications.
Patient Sequence No: 1, Text Type: N, H10
[75602637]
It was reported to gore that the physician was implanting a gore? Viatorr? Tips endoprosthesis for a transjugular intrahepatic portosystemic shunt (tips) procedure on (b)(6) 2016. On (b)(6) 2016 the patient showed signs of infection around the tips device. Confirmed by positron emission tomography (pet). The pathogen enterococcus faecium was diagnosed via blood culture. The patient suffered from sepsis. The patient received antibiotic therapy. The patient has a history of liver cirrhosis, chronic pancreatitis, removal of gallstones, stent implantation in biliary tract, cholestasis. The patient was admitted to the intensive care unit several times from last year to today.
Patient Sequence No: 1, Text Type: D, B5
[76785204]
Implant date (b)(6) 2016 was added.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007284313-2017-00131 |
| MDR Report Key | 6580896 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-22 |
| Date of Report | 2017-05-23 |
| Date of Event | 2016-10-24 |
| Device Manufacturer Date | 2016-06-22 |
| Date Added to Maude | 2017-05-22 |
| 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 | 2017-05-22 |
| Catalog Number | PT108275 |
| Lot Number | 15203075 |
| Device Expiration Date | 2019-06-22 |
| 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 | 2017-05-22 |