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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 COVERED STENT; STENT, ILLIAC
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ATRIUM MEDICAL ADVANTA V12 COVERED STENT; STENT, ILLIAC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Aneurysm (1708); Cardiac Arrest (1762); Hematoma (1884); Occlusion (1984); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study, proposed potential benefits attributable to the minimally invasive nature of pevar while demonstrating cost-effectiveness despite the additional cost f closure devices.[(b)(4)].
 
Event Description
Received an article titled "successful percutaneous access for endovascular aneurysm repair is significantly cheaper than femoral cutdown in a prospective randomized trial" published in the journal of vascular surgery.The article compared percutaneous femoral access for endovascular aneurysm repair (pevar) with surgical cutdown for femoral access (cevar).Per the article, adverse events included pain, aneurysm rupture, cardiac arrest, blood loss, occlusion and hematoma.
 
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Brand Name
ADVANTA V12 COVERED STENT
Type of Device
STENT, ILLIAC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8115871
MDR Text Key128859938
Report Number3011175548-2018-01403
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,health professional,s
Reporter Occupation Physician
Type of Report Initial
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
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 Received11/12/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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