MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-08 for GORE? VIATORR? TIPS ENDOPROSTHESIS PTB8108275 manufactured by W.l. Gore & Associates.
[99364131]
A review of the manufacturing records for the device verified that the lot met all pre-release specifications. The device remains implanted so no engineering investigation could be performed. (b)(4). An issue in which a medical device has an obstructed lumen.
Patient Sequence No: 1, Text Type: N, H10
[99364132]
It was reported that the physician was implanted a gore? Viatorr? Tips endoprosthesis for a transjugular intrahepatic portosystemic shunt (tips) procedure. The device was implanted on (b)(6) 2017. On (b)(6) 2017 the device was imaged and stent occlusion was observed. The device had initially been dilated to 8mm in diameter. The physician went back and re-dilated the device to 10mm. Following the procedure the stent was patent and the patient was doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00049 |
| MDR Report Key | 7252084 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-08 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-11-30 |
| Device Manufacturer Date | 2017-07-17 |
| Date Added to Maude | 2018-02-08 |
| 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 | ASHLEY MAROSTICA |
| 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 | 2018-02-08 |
| Catalog Number | PTB8108275 |
| Lot Number | 16507194 |
| 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. Required No Informationntervention | 2018-02-08 |