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

Device Problems Obstruction of Flow (2423); Positioning Problem (3009)

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article titled early and late outcome of covered and non-covered stents in the treatment of coarctation of aorta - a single centre experience.Purpose: stenting of coarctation of aorta with covered or uncovered stents is the accepted modality of treatment in older children and adults.We attempted to study the early and late outcomes after stenting of native and recurrent coarctation of aorta with uncovered and covered stents.Method: this is a retrospective study of patients who underwent stenting for coarctation of aorta with covered or non-covered stents at our institute.Early and late outcome for both the groups were studied.Per the article adverse events occurred including access site complications, occlusion and malposition.

Manufacturer Narrative

The study described in this article is for coarctation of the aorta.The advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.Renal approval includes 5 mm, 6 mm and 7 mm diameter advanta v12 sizes.Per the article adverse events occurred including access site complications, occlusion and malposition.In regards to access site complications there are many factors that include the techniques used by the interventionalist such as localization of the access site and the number of punctures (at time of femoral cannulation), the dilator sheath size and time of sheath removal.The device used was a large diameter advanta v12, the smallest recommended sheath size is 9fr based on the information provided on the product label.A 9fr introducer sheath is slightly larger than 3mm in diameter.The method of closure is up to the physician in regards to sealing the entre site of the sheath.Occlusions of the stent can occur if the patients did not follow their individual anticoagulants and antiplatelet medications.Based on the study some patients had been treated as far back as 2003.Stent malpositioning is dependent of the physician in regards to initial placement and vessel /stent size determination as well as wall apposition and post dilation of the stent to ensure the stent is opposed to the vessel wall.The instructions for use in the potential adverse effects section state the following: bleeding or hematoma at the puncture site restenosis of stented lesion stent misplacement, migration or deformation systemic embolization or thromboembolic episodes vascular thrombosis based on the details of the complaint there is no evidence to conclude or confirm that the devices in question were directly responsible for the conditions experienced.H3 other text: not available for return.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10671392
• MDR Text Key: 211241329
• Report Number: 3011175548-2020-01221
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention