MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-04 for GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[182048082]
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. Investigation is ongoing. This event is reported as death, although evidence of device thrombis was not determined from radiologic and medical event records. The gore conformable gore? Tag? Thoracic endoprosthesis and gore? Viabahn? Endoprosthesis devices were considered and were determined not to be reportable or part of the complaint.
Patient Sequence No: 1, Text Type: N, H10
[182048083]
The following was reported by the product specialist: in (b)(6) patient underwent right carotid to left carotid, left carotid to left subclavian bypass, tevar procedure for thoracic aortic aneurysm with innominate chimney using a gore? Viabahn? Vbx balloon expandable endoprosthesis (vbx) stents (11mm x 79mm and 11mm x 39mm). The patient was identified as too high risk to perform an open repair. The patient also underwent open fenestration of abdominal aortic dissection and aaa repair with none gore devices in (b)(6) 2019. On (b)(6) 2019, a head ct was performed, r mca occlusion was identified and the patient was taken to the or. The patient underwent right transcervical carotid artery cutdown, suction thrombectomy and relined the vbx with 2 gore? Viabahn? Endoprosthesis stents. On (b)(6) 2019, a repeat ct of the head now showed bilateral cerebral infarcts with bilateral posterior cerebral artery occlusions. On (b)(6) 2019 the patient had no meaningful neurologic recovery during this post-operative course and passed away on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00147 |
| MDR Report Key | 9789274 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | NICK LA FAVE |
| 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? VBX BALLOON EXPANDABLE ENDOPROSTHESIS |
| Generic Name | STENT, ILIAC |
| Product Code | NIO |
| Date Received | 2020-03-04 |
| 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. Death | 2020-03-04 |