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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Rupture (2208); Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Event Type  Injury  
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
Event Description
Article received: claire van der riet, m.,.(2021).Outcomes of advanta v12 covered stents after fenestrated endovascular aneurysm repair.Journal of endovascular therapy, 1-7.Purpose: this study presents midterm clinical outcomes and patency rates of the advanta v12 becs used as a bridging stent.Method: all patients treated with fevar with at least 1 advanta v12 becs were included from 2 large-volume vascular centers between january 2012 and december 2015.These patients had, in total, 457 fenestrations stented with an advanta v12 becs: 174 left renal arteries (lras), 179 right renal arteries (rras), 90 superior mesenteric arteries (smas), and 14 celiac trunks.Conclusion: the advanta v12 becs used as bridging stent in fevar showed low complication and reintervention rates at 3 years.A substantial number of fevar patients required a reintervention, but most were not becs related.Per the article adverse events included: blood loss, dissection, misplacement, occlusion, rupture, stenosis.
 
Manufacturer Narrative
Article reviewed: vander riet, et al.2021.Outcomes of advanta v12 covered stents after fenestrated endovascular aneurysm repair.Journal of endovascular therapy, 28(5):700-706.The subject article is a two-center retrospective cohort study of 194 fenestrated endovascular aneurysm repair (fevar) patients with a mean age of 72.2 +/- 8.0 years who consecutively underwent elective fevar for a pararenal abdominal aortic aneurysms (paaa) between january 2012 and december 2015.A total of 457 visceral arteries were stented with an advanta v12 balloon-expandable covered stents (becs).Median (interquartile range) follow-up time was 24.6 (1.6, 49.9) months.The fevar procedure was technically successful in 93% of the patients.This complaint is based on information found within a article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.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.Attempts to obtain the device lot information was conducted but unsuccessful.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.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.
 
Event Description
N/a.
 
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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 Key11998322
MDR Text Key256165357
Report Number3011175548-2021-00666
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/11/2022
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 Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/04/2021
Initial Date FDA Received06/15/2021
Supplement Dates Manufacturer Received12/09/2022
Supplement Dates FDA Received12/11/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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