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

Model Number 85343

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the stent shifted while pushing through the introducer sheath.

Manufacturer Narrative

The investigation into the reason for the complaint is difficult due to the fact that the device was not returned.The introducer sheath used in the case was also not returned.During the final lot qualification data shows that all test samples were able to pass through the 6fr introducer sheath without issue.Since december of 2013 over (b)(4) test units have been passed through the introducer sheath without a failure for the inability of the stent to pass through the introducer sheath.The product in question has also been subjected to simulated use in a tortuous iliac artery model whereas the stent delivery system is advanced contra laterally over the iliac arch through a 6fr 55cm long cook check flow performer introducer sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during design verification testing of the product.None of the samples tested had an issue regarding stent dislodgments while passing through the introducer sheath.The details indicate that the sheath used was a 12fr sheath.The 6mm x 22mm product requires a 6fr introducer sheath as specified on the label.The 12fr sheath is more than double the inner diameter of the 6fr sheath.When asked what other devices may have been tracked through the 12fr introducer sheath the reply was an additional v12 covered stent.The anaconda fenestrated graft that was used in this case would not have been able to be deployed through a 6fr sheath and is likely that the anaconda graft was placed through the 12fr introducer sheath prior to the advancement of the v12 6mm x 22mm stent.Engineering summary: a full review of the catheter lot history records for the device in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.This inspection requires that the catheter lot must pass the following: ability of the stent and delivery system to be passed through the labeled introducer sheath.Ability to deploy the stent at nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.Ability of the delivery system to withstand 10 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs.Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.Clinical evaluation: a stent can become dislodged if the vessel is calcification or has severe disease, if the vessel has not been properly pre-dilated, if the stent has not been sized correctly and if the device has to advance through other grafts or stents.The instructions for use state, "use of the icast is contraindicated in lesions that are heavily calcified or when it is not possible to access the site with standard placement techniques." insufficient stent securement while advancing to the target may lead to dislodgement and the need for removal of the stent delivery system.This event may be associated with the potential harm of a delay in treatment as well as the need for additional medical or surgical intervention.

• Brand Name: ATRIUM ADVANTA V12 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: 5900834
• MDR Text Key: 52900154
• Report Number: 1219977-2016-00187
• Device Sequence Number: 1
• Product Code: NIO
• 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: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2018
• Device Model Number: 85343
• Device Catalogue Number: 85343
• Device Lot Number: 227021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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
• Patient Age: 63 YR
• Patient Weight: 75