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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA VS GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL ADVANTA VS GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Occlusion (1984); Sepsis (2067)
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, axillary to iliac/femoral vein bypass can salvage functioning ipsilateral fistula threatened by occluded upper central vein and relieve their upper limb obstructive venous symptoms.
 
Event Description
Received a study titled "extra-anatomical veno-venous surgical bypass for central vein occlusion." the study was to describe an extra-anatomical venous bypass surgical procedure performed to maintain vascular access and reduce the symptoms of swelling of the ipsilateral upper limb, neck and face in patients that underwent bypass between november 2009 and april 2013.Per the article adverse events occurred including infection, sepsis/acinetobacter, hemorrhage and occlusion.
 
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Brand Name
ADVANTA VS GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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 Key7332556
MDR Text Key102181940
Report Number3011175548-2018-00238
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Physician
Type of Report Initial
Report Date 03/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
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 Received02/26/2018
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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