MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[79575742]
(b)(4). A device lot number was not provided and the device is unavailable for analysis; therefore, an investigation is unable to be performed and a cause of the reported event is unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
[79575743]
It was reported a patient underwent whipple surgery for pancreatic cancer. Following this surgery, a portal vein thrombectomy was performed, during which a transjugular intrahepatic portosystemic shunt (tips) procedure was also performed and two viatorr tips endoprostheses were implanted ((b)(6) 2016). A review of the patient's medical records show a reintervention on (b)(6) 2016 via thrombectomy for a narrowing in a previously implanted icast stent that was placed in the superior mesenteric vein at some point prior to the tips procedure. Additional revisions via angioplasty were performed on (b)(6) 2016. There were additional procedures (reasons unknown) performed (b)(6) 2016. An embolization procedure was performed on (b)(6) 2016, at which point a previously implanted viabahn device was noted in the patient's records. The reason for the viabahn implant is not available; however, the device appeared to begin mid viatorr and extend through the chainlink portion into the portal vein. On (b)(6) 2017, the two viatorr devices and the viabahn device were removed via snare and catheters due to infection. It is not known whether the devices were infected or if the patient was bacteremic. Following removal of the stents, the physician discovered a fistula from the bowel to the portal vein, which was most likely unintentionally created during the previous whipple surgery. The doctor believes this was the source of infection, not the gore grafts. The fistula was closed with an amplatzer plug. The patient's current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2017-00176 |
| MDR Report Key | 6699464 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-06-29 |
| Date Added to Maude | 2017-07-10 |
| 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 | 0 |
| Brand Name | GORE VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2017-07-10 |
| 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. Other; 2. Required No Informationntervention | 2017-07-10 |