MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for GORE VIABAHN? ENDOPROSTHESIS - 3 manufactured by W.l. Gore & Associates.
[186737974]
Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided. The device was not returned. Consequently, direct product analysis was not possible. Additional information about this event could not be obtained. As a result, no conclusion can be drawn. All information has been placed on file for use in tracking and trending.
Patient Sequence No: 1, Text Type: N, H10
[186737975]
Published abstract "two-year evaluation of fenestrated and parallel branch endografts for the treatment of juxtarenal, suprarenal,and thoracoabdominal aneurysms at a single institution" (mohsen bannazadeh, m. D. , william e. Beckerman, m. D. , adam h. Korayem, m. D. , and james f. Mckinsey, m. D. , new york, ny; copyright 2019 published by elsevier inc. On behalf of the society for vascular surgery; https://doi. Org/10. 1016/j. Jvs. 2019. 03. 058) was reviewed. The abstract discusses the mortality, graft patency, renal function, complication, and reintervention rates for fenestrated and parallel endografts in complex aortic aneurysms repairs from august 2014 to march 2017 in a single center. The abstract reported in the reintervention, branch reintervention, and endoleaks section under the fenestrated group identified 2 type iii endoleaks and 1 gutter endoleak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00040 |
| MDR Report Key | 9599114 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-03-04 |
| Date of Event | 2017-09-07 |
| Date Added to Maude | 2020-01-16 |
| 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 | CRAIG BEARCHELL |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL ECHO RIDGE B/P |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE VIABAHN? ENDOPROSTHESIS - 3 |
| Generic Name | NIP |
| Product Code | PFV |
| Date Received | 2020-01-16 |
| 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 | 2020-01-16 |