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

Device Problem Activation Problem (4042)

Patient Problems Unspecified Infection (1930); Valvular Stenosis (2697); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article draft received: van der riet, c.E.(n.D.).Butterfly: bi-center retrospective observational study to assess stent integrity and flare geometry after fenestrated endovascular aneurysm repair.Not published yet.Purpose: this study presents midterm clinical outcomes and patency rates of the advanta v12 becs used as a bridging stent.Method: this retrospective study includes 194 fevar patients with a mean age of 72.2 ± 8.0 years.A total of 457 visceral arteries were stented with an advanta v12 becs.Conclusion: study unfinished.Per the article adverse events included stenosis, thromboembolic, inadequate implantation, dissection and infection.

Manufacturer Narrative

Additional information.This complaint is based on information within an article and no specific device information has been provided.As there is insufficient details of an actual device malfunction or adverse event that occurred the complaint cannot be confirmed.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.It is important to mention that advanta v12 balloon expandable covered stent ifu clearly stated that potential adverse effects include, but may not be limited to: restenosis of stented lesion, systemic embolization or thromboembolic episodes, vascular thrombosis and stent misplacement, migration or deformation.Conclusion: although the study was a two-centered, retrospective, observational research of 194 fevar patients who had total of 457 visceral arteries stented with an advanta v12 becs and showed overall low complication and reintervention rates at 3 years, however 24 advanta v12 becs-associated complications were diagnosed during follow up, and 16 of 24 becss (67%) with a complication underwent a reintervention, and this was successful in 12 cases.The authors claimed that reported technical success and short-term target vessel patency were similar to results of previous publications.After review of the details provided, one can infer that getinge¿s advanta v12¿ stents performed as expected and the major risk factors for developing stent complications were: a mismatch of the diameter of the becs with the target vessel or the fenestration can result in loss of fixation and seal.Increased length of the flared part of the becs to provide stability and seal comes at the cost of increased risk for stenosis and occlusion.Too much oversizing of the distal end of the becs in the visceral arteries may increase the risk for dissections and dissection associated occlusions.Caudal migration of the fsg with displacement of the becs can result in stent fracture and compression of the becs between the fenestration and the target vessel, potentially occluding the target vessel.H3 other text: product not returned.

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
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11513797
• MDR Text Key: 240588664
• Report Number: 3011175548-2021-00318
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention