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 2016-09-30 for ATRIUM ADVANTA V12 LARGE DIAMETER COVERED STENT manufactured by Atrium Medical Corporation.
[55990747]
On completion of the investigation a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[55990748]
Received an article titled "experience with the atrium advanta covered stent for aortic obstruction" published in the journal of interventional cardiology. The article assessed the efficacy, safety and clinical outcomes of the advanta v12 covered stent in management of coarctation of the aorta (coa) in 17 patients between october 2009 and february 2012. Per the article the implantation of the advanta v12 stent for the treatment of coa is safe and effective in the early term. Noted in the article were adverse events: 2 patients required unplanned re-intervention. Mild chest pain occurred in 3 patients after implantation, but disappeared within 24 hours. Five children required medication for blood pressure control.
Patient Sequence No: 1, Text Type: D, B5
[58275312]
Investigation: we are unable to fully investigate this report as no product number, lot number or sample was provided. There is no indication this event is due to a device failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219977-2016-00209 |
| MDR Report Key | 5989739 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-07 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-09-30 |
| 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 Contact | MS. LYNDA MCLAUGHLIN RN, CCRN-K |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer Phone | 6038645470 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 5 WENTWORTH DRIVE |
| Manufacturer City | HUDSON NH 03051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRIUM ADVANTA V12 LARGE DIAMETER COVERED STENT |
| Generic Name | PTFE COVERED STENT |
| Product Code | PNF |
| Date Received | 2016-09-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | 5 WENTWORTH DRIVE HUDSON NH 03051 US 03051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-30 |