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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperplasia (1906); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Per the study both bare and covered stent implantation for aortic coarctation is a rare and efficacious treatment.

Event Description

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.

Manufacturer Narrative

Email received from physician: "no advanta stent was associated to complications in that article.".

• 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: 5990326
• MDR Text Key: 56033311
• Report Number: 1219977-2016-00207
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/12/2016

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: 09/12/2016
• 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