• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Manufacturer Narrative
On completion of the investigation a follow-up report will be submitted.
 
Event Description
Received an article: chassin-trubert, l.E.(2019).Midterm follow-up of fenestrated and scalloped physician modified endovascular grafts for zone 2 tevar.Journal of endovascular therapy, 377-384.Purpose: to investigate the midterm outcomes of scalloped or fenestrated physician modified endovascular grafts for zone 2 thoracic endovascular aortic repairs.Method: between nov 2013 and may 2019, 54 consecutive patients were treated with thoracic pmegs modified with scallops and fenestrations for the left subclavian artery.Conclusion: scalloped or single fenestrated pmegs for the lsa appear to be durable and safe in the midterm.Per the article deaths occurred within the study period.
 
Manufacturer Narrative
Article reviewed: chassin-trubert et al.2020.Midterm follow-up of fenestrated and scalloped physician-modified endovascular grafts for zone 2 tevar.J endovasc ther; 27(3):377-384.The subject article is a two centers retrospective cohort study of 54 consecutive patients (mean age 63 years; 41 men) who were treated with thoracic fenestrated physician-modified endovascular grafts (pmegs) modified with 7 scallops or 47 fenestrations for the left subclavian artery (lsa) between november 2013 and may 2019.The purpose of the study was to investigate the midterm outcomes of scalloped or fenestrated physician-modified endovascular grafts (pmegs) for zone 2 thoracic endovascular aortic repairs (tevar).This complaint is based on information found within an 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: the instructions for use clearly states that potential adverse effects of advanta v12 balloon-expandable stent include, but may be not limited to: inadequate implantation or intimal trauma, restenosis of stented lesion, stent misplacement, migration or deformation, systemic embolization or thromboembolic episodes.Although four of the lsa fenestrations were unstented, 3 (6%) lsas were unintentionally covered, 2 patients developed a type ii endoleak and required distal extension of covered lsa stents, one patient suffered spinal cord ischemia with irreversible bilateral paraplegia, however considering the study design, high technical success rate 94% and the fact that all the lsas remained clinically and radiologically patent and there were no conversions to open repair, ruptures, retrograde dissection, stent fracture, migrations, or other aortic complications, one can infer that the getinge¿s advanta v12 balloon expandable covered stents performed as expected.H3 other text: not available for return.
 
Event Description
N/a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11517520
MDR Text Key240738683
Report Number3011175548-2021-00334
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,Literature,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/28/2022
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 02/22/2021
Initial Date FDA Received03/18/2021
Supplement Dates Manufacturer Received10/27/2022
Supplement Dates FDA Received10/29/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
-
-