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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 COVERED STENT; STENT, RENAL
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ATRIUM MEDICAL ADVANTA V12 COVERED STENT; STENT, RENAL Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
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, endovascular approach for the treatment of bilateral haas that minimizes the risk of ischemic complications by preserving pelvic circulation.
 
Event Description
Received an article titled "preservation of pelvic circulation in one stage endovascular repair of bilateral hypogastric artery aneurysms" published in the annals of vascular surgery.The article reported a case of one stage endovascular repair of bilateral haas preserving pelvic circulation.Per the article adverse events included endoleaks.
 
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Brand Name
ADVANTA V12 COVERED STENT
Type of Device
STENT, RENAL
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 Key8130274
MDR Text Key129245364
Report Number3011175548-2018-01442
Device Sequence Number1
Product Code NIN
Combination Product (y/n)N
Reporter Country CodeGR
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 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
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
Device Age YR
Date Manufacturer Received11/16/2018
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;
Patient Age67 YR
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