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

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problems Perforation (2001); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

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.

Manufacturer Narrative

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.

• 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: 5989735
• MDR Text Key: 55990881
• Report Number: 1219977-2016-00208
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/27/2016
• Was Device Evaluated by Manufacturer?: No
• 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