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.
[55990881]
On completion of the investigation a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[55990882]
Received an article titled "large-diameter graft-stent (advanta v12) implantation in various locations: early results" published in cardiology in the young. The article reported the early results of the treatment of various cardiovascular obstructions by the implantation of the new ptfe covered stent in 16 patients between july 2009 and april 2010. Per the study the initial results show that the covered advanta v12 large diameter stent is safe and effective in the immediate treatment of various cardiovascular obstructions. The article noted adverse events: incorrect sizing in 2 patients: difficult placement in one patient with multiple congenital pulmonary artery stenosis. Perforation of right ventricular outflow tract in one patient
Patient Sequence No: 1, Text Type: D, B5
[58619792]
Clarification received from physician: "there was only one problem related to the stent in one patient that was readmitted one week after stent placement with an bent stent causing severe obstruction of the aortic lumen; the patient needed a urgent intervention by placing a second stent to correct the problem. No further information is available. " engineering analysis: the article indicates that the v12 large diameter stent was placed within a coarctation of the aorta and after one week the patient was re-admitted as the stent had bent causing a severe obstruction. There have been no images of the stent upon initial deployment or of the stent once discovered that it had been bent. If images were provided they may have provided additional details of how the stent was deployed and if the stent was well opposed to the vessel wall. Without this detail a root cause of the complaint is difficult to determine. As the lot number of the device in question was not provided a review of the manufacturing and quality inspection paperwork including quality control lot qualification information could not be reviewed. Engineering summary: based on the lack of catheter lot number information, images or details a root cause into the complaint cannot be assessed. Conclusion: atrium cannot conclude that the device failure is the result of the manufacturing process, material defect or non-conformance to design requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219977-2016-00208 |
| MDR Report Key | 5989735 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-07 |
| Date Mfgr Received | 2016-10-25 |
| 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 | N |
| 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 |