MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ADVANTA V12 LARGE DIAMETER COVERED STENT; PTFE COVERED STENT

Device Problem Insufficient Information (3190)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

Per the study these initial results show that the covered advanta v12 ld stent is safe and effective in the immediate treatment of coarctation of the aorta through a low profile delivery system.

Event Description

Received an article titled "coarctation of the aorta treated with the advanta v12 large diameter stent: acute results" published in catheterization and cardiovascular interventions.The article reported the early results of treatment of coarctation of the aorta by dilation with ptfe covered stents in 25 patients between (b)(6) 2008 and (b)(6) 2009.Per the article it was noted in the article that one patient was re-catheterized five months after implantation for further dilation of the stent from 12mm to 15mm to match the increased diameter of the transverse arch.

Manufacturer Narrative

Answers received from physician: "this was a standard re-dilation of the stent to adjust for somatic growth.It was not the result of a device failure.".

• Brand Name: ATRIUM ADVANTA V12 LARGE DIAMETER COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5989731
• MDR Text Key: 55991596
• Report Number: 1219977-2016-00211
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention