MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-23 for ADVANTA V12 COVERED STENT manufactured by Atrium Medical Corporation.
[179301741]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, these preliminary results on a small series of patients showed that the gore viabahn stent graft can be used to connect the fenestrations and the branches of the stent grafts with the target arteries. No significant difference with the others stents used in this indication was observed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[179301742]
Received an article titled preliminary study of the gore viabahn stent graft as a bridge between branched or fenestrated stent grafts and target arteries. Purpose: the aim of this study was to evaluate the role of the endovascular treatment compared to the surgical treatment in patients presenting with a ruptured aneurysm and a favorable anatomy. Method: this monocentric retrospective study included all the patients treated for a true ruptured aneurysm eligible to an endovascular treatment between january 2006 and december 2017. Conclusion: these preliminary results on a small series of patients showed that the gore viabahn stent graft can be used to connect the fenestrations and the branches of the stent grafts with the target arteries. No significant difference with the others stents used in this indication was observed. Per the article adverse events included dissection of the vessel and bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00138 |
| MDR Report Key | 9624886 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-01-23 |
| 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 | MS. LYNDA MCLAUGHLIN |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTA V12 COVERED STENT |
| Generic Name | STENT, RENAL |
| Product Code | NIN |
| Date Received | 2020-01-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-23 |