MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for GORE VIABAHN? ENDOPROSTHESIS - 3 manufactured by W.l. Gore & Associates.
[188373681]
Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided. The device(s) 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
[188373682]
The following abstract was reviewed: "performance of viabahn balloon-expandable stent compared with self-expanding covered stents for fenestrated-branched endovascular aortic repair" (fernando motta, m. D. ; frederico e. Parodi, m. D. ; jason r. Crowner, m. D. ; luigi pascarella, m. D. ; katharine l. Mcginigle, m. D. ; william a. Marston, m. D. ; melina r. Kibbe, m. D. ; mark a. Farber, m. D. ; savs22; journal of vascular surgery, january 2020, volume 71, number 1; page e28 & e29. The objective of the physician sponsored investigational device exemption trial was to compare the performance between gore? Viabahn? Vbx balloon expandable endoprosthesis and self-expanding covered stents (gore? Viabahn? Endoprosthesis & fluency? Plus endovascular stent graft) (ses) used as bridging stents for directional branches during fenestrated-branched endovascular aneurysm repair of complex aortic aneurysms. The median patient age was 71 with 70% male. Total number of vessels incorporated to repair was 977 of which 179 were branch vessels (54 celiac artery, 56 superior mesenteric artery, 38 right renal artery, and 31 left renal artery). Primary patency rates at 24 months for vbx was 98. 1%, and,98. 6 for ses. Freedom from endoleaks (vbx - 97. 3, ses 98. 6%), freedom from secondary intervention (vbx - 91. 5%, ses 95%), and freedom branch instability (vbx - 95. 5%, ses 97. 3%). The abstract reports the vbx demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00120 |
| MDR Report Key | 9740741 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-01 |
| Date Added to Maude | 2020-02-21 |
| 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 | 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 | 2020-02-21 |
| 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 | 2020-02-21 |