MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-05 for GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION PTB8108275 manufactured by W.l. Gore & Associates.
[141168188]
The patient weight or date of birth were not available. The imaging evaluation was able to confirm the physician? S event description that balloon thrombectomy was being performed. No images were provided of the device after it had been dislodged to the right atrium, so the distance that the device was dislodged was unable to be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[141168189]
It was reported the physician deployed a gore? Viatorr? Tips endoprosthesis. The patient had preexisting portal vein thrombosis. One day later, the physician was performing a balloon thrombectomy. During one of the passes, the viatorr? Device was dislodged to the right atrium. The physician was able to pull the expanded device out through the internal jugular, which enlarged the access site. A 16 fr sheath with a suture around it was used to achieve hemostasis. A vascular surgeon closed the access site once the procedure was finished. The patient was doing well following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2019-00098 |
| MDR Report Key | 8489480 |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-11 |
| Date of Event | 2018-12-15 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-04-05 |
| 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 | DAN KITTERMAN |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | 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 WITH CONTROLLED EXPANSION |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2019-04-05 |
| Catalog Number | PTB8108275 |
| Lot Number | 18570143 |
| 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. Other | 2019-04-05 |