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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

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 ptfe covered stent in 16 patients between july 2009 and april 2010.Per the study these initial results show that the covered advanta v12 large diameter stent is safe and effective in the immediate treatment of various cardiovascular obstructions.Noted in the study were adverse events: recoiling of the open-cell-designed stent with unsatisfactory results was observed in seven patients, in whom re-dilation of the v12 stent became necessary, either by ballooning or placement of a second stent.

Manufacturer Narrative

Engineering analysis: the article indicates that the v12 large diameter stent recoil was unsatisfactory in seven patients, in whom re-dilation of the v12 stent became necessary, either by ballooning or placement of a second stent.The details provided do not elaborate on the claim further.Assumed diameters were not provided or actual deployed diameters post nominal inflation of the stents.The recoiled stent diameters are clearly listed on both the outer box of the v12 and the inner pouch label.The instructions for use specify the following, "measure the inner diameter of the vessel to determine the appropriate diameter stent." the advanta v12 stent is labelled as the outer diameter.Without deployed stent diameters or images there is nothing to substantiate the claims that the stent recoiled too much.A review of the mechanical properties and dimensions of the stent lot would have been performed if the lot numbers of the finished devices were provided.The quality inspection data (certificate of conformance) would have revealed that the mechanical and dimensional properties of the stent used in the device lot conform to the established specifications found within the stent specification drawing.The mechanical properties include: yield stress, ultimate tensile strength, elongation, grain size, inclusion size and distribution, and stent feature dimensional measurements.As the production lot number was not supplied this evaluation could not be performed.The product lot qualification data would have also been reviewed to ensure the recoiled stent diameter and length were within specifications.Engineering summary: atrium cannot conclude based on the details provided that the devices in this article recoiled too much without data to support the claim.The recoiled stent diameter is clearly listed on the product label at post nominal inflation and post rated burst pressure.The physician/author of the article replied that "no advanta stent was associated with this adverse event." conclusions of the article indicate that the covered advanta v12 large-diameter stent is safe and effective in the immediate treatment of various cardiovascular obstructions.

• 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: 5989740
• MDR Text Key: 55990715
• Report Number: 1219977-2016-00210
• 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: 10/20/2016
• 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