MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for GORE? VIATORR? TIPS ENDOPROSTHESIS PTB086275W manufactured by W.l. Gore & Associates.
[109236691]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109236692]
It was reported to gore that the physician was implanting a gore? Viatorr? Tips endoprosthesis for a treatment of the portal vein hypertension due to the cirrhosis. The device was advanced through a 10fr cook rups100 sheath via a super stiff guide wire. After the device was well positioned, the physician pulled back the sheath to deploy the chainlink portion of device, then started initiating deployment of lined region. However when the lined region was deployed half, a resistance was reportedly felt and the deployment was not able to continue. The physician exchanged the 10fr sheath with an 11fr sheath then retracted the partially deployed viatorr? Device out of the patient through the 11fr sheath, there was no reported issue or injury to the patient during the device retraction. The physician used another viatorr? Device of same size to continue the procedure. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00158 |
| MDR Report Key | 7528976 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-04-18 |
| Device Manufacturer Date | 2017-09-25 |
| Date Added to Maude | 2018-05-21 |
| 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 | HELEN HUANG |
| 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 | 0 |
| Brand Name | GORE? VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2018-05-21 |
| Returned To Mfg | 2018-05-10 |
| Catalog Number | PTB086275W |
| Lot Number | 17268183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2018-05-21 |