MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS BXA062902E manufactured by W.l. Gore & Associates.
[188178540]
Patient? S year of birth : 1955. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188178541]
The patient was implanted with a fenestrated abdominal aortic aneurysm graft where a gore? Viabahn? Vbx balloon expandable endoprosthesis was intended to be implanted as a branch device to treat the mesenteric artery. It was reported to gore that after the gore? Viabahn? Vbx balloon expandable endoprosthesis (6 mm x 59 mm) was successfully deployed at the target lesion, the device was dilated with a 10 mm x 20 mm balloon from an unknown manufacturer. After the dilatation the computer tomography angiography (cta) revealed a rupture of the endoprosthesis which lead to an endoleak. Therefore the decision was made to implant an advanta stent (getinge) to perform a relining of the implanted vbx endoprosthesis. After the advanta stent (getinge) was successfully deployed and also dilated with a 10 mm x 20 mm balloon the cta revealed that the advanta stent (getinge) ruptured into two pieces. At this stage the procedure was completed without additional device placement. It was reported to gore that the physician is planning to reline the ruptured vbx endoprosthesis and the broken advanta stent (getinge) with a gore? Viabahn? Endoprosthesis within the next upcoming days. It was stated that the patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00153 |
| MDR Report Key | 9800772 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-03 |
| Device Manufacturer Date | 2019-06-03 |
| Date Added to Maude | 2020-03-06 |
| 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 | SIBYLLE STAERK |
| 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? VBX BALLOON EXPANDABLE ENDOPROSTHESIS |
| Generic Name | STENT, ILIAC |
| Product Code | NIO |
| Date Received | 2020-03-06 |
| Catalog Number | BXA062902E |
| Lot Number | 20905268 |
| 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. Hospitalization | 2020-03-06 |