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.
[56033311]
Per the study both bare and covered stent implantation for aortic coarctation is a rare and efficacious treatment.
Patient Sequence No: 1, Text Type: N, H10
[56033312]
Received an article titled "from bare to covered: 15 year single center experience and follow-up in trans-catheter stent implantation for aortic coarctation" published in catheterization and cardiovascular interventions the article reported comparatively 15-year experience of bare and covered stent implantation for coarctation in a single tertiary referral center. Included were 143 patients between 1997 and 2011. Per the article the following were the adverse events: one femoral artery stenosis post surgical hemostasis. Fifteen with restenosis related to neointimal hyperplasia (proliferation and migration of vascular smooth muscle cells primarily in the tunica intima, resulting in the thickening of arterial walls and decreased arterial lumen space triggered by injury to the intima during catheterization procedures). One had an arterio-venous fistula - self limiting. One with radial access developed hand ischemia.
Patient Sequence No: 1, Text Type: D, B5
[57630951]
Email received from physician: "no advanta stent was associated to complications in that article. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219977-2016-00207 |
| MDR Report Key | 5990326 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-12 |
| Date Mfgr Received | 2016-10-01 |
| 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 |