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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 Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the article endovascular stenting of coarctation of the aorta results in significant reduction in sbp - [(b)(4)].
 
Event Description
Received an article: hamid, t.E.(2015).Benefit of endovascular stenting for aortic coarctation (coa) on systemic hypertension in adults.Archives of cardiovascular disease, 626-633.Purpose: to assess systemic hypertension control and the need for antihypertensive therapy after coa stenting in adults.Per the article product malfunctions included recoil and fracture.
 
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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 Key7948418
MDR Text Key123359763
Report Number3011175548-2018-01146
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2018
Initial Date FDA Received10/09/2018
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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