MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-07-30 for ADVANTA V12 COVERED STENT manufactured by Atrium Medical Corporation.
[152675056]
We are unable to fully investigate this report as no product number, lot number or sample was provided. It is not known what relationship the advanta v12 has to the reported adverse events. The study concluded fb-evar was feasible for post-dissection thoracoabdominal aneurysm. Despite the associated peri-operative risk and high probability of planned or unplanned reintervention, the procedure led to favorable aortic remodeling with false lumen thrombosis and aneurysm regression. Based on the information available atrium has determined that the events described are not related to a product failure. Not available for return.
Patient Sequence No: 1, Text Type: N, H10
[152675057]
Received an article titled fenestrated or branched endovascular aortic repair for post-dissection thoracoabdominal aortic aneurysm. Purpose: fenestrated or branched endovascular aortic repair (fb-evar) usually represents the last stage in endovascular treatment of post-dissection aneurysm after thoracic endograft coverage of entry tear and false lumen embolization. Method: between january 2014 and december 2017, consecutive patients who underwent fb-evar for treatment of post-dissection thoracoabdominal aneurysm (taaa) in one center were included and retrospectively reviewed. Per the article adverse events included: type iii endoleak, spinal cord ischemia, systemic inflammatory response syndrome, respiratory failure, acute kidney injury, bleeding complications and wound complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2019-00817 |
| MDR Report Key | 8841976 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-30 |
| Date Mfgr Received | 2019-07-22 |
| Date Added to Maude | 2019-07-30 |
| 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 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 | 2019-07-30 |
| 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 | 2019-07-30 |