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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ADVANTA SST GRAFTS
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ATRIUM MEDICAL CORP. ADVANTA SST GRAFTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Necrosis (1971); Tissue Damage (2104)
Event Type  Injury  
Event Description
Received an article submitted to the journal of cardiovascular surgery titled "long term results of ptfe trilaminate graft versus venous graft and composite graft for below-the-knee revascularization." the study consisted of a retrospective review of sixty-one patients from (b)(6) 2004 to (b)(6) 2013.Per the study, five patients in group c - ptfe graft and autologous great saphenous vein (agsv) composite - presented with wound complications: necrosis with major tissue loss.
 
Manufacturer Narrative
A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, the long term results of the use of advanta sst graft below the knee (btk) and distal revascularizations are promising, with significant lower duration of the operation and wound complications.If any further info is obtained then a follow up report will be submitted.
 
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Brand Name
ADVANTA SST GRAFTS
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key4028171
MDR Text Key4728572
Report Number1219977-2014-00228
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Type of Report Initial
Report Date 07/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2014
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 Received07/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
AUTOLOGOUS GREAT SAPHENOUS VEIN GRAFT,; BRAND NOT IDENTIFIED
Patient Outcome(s) Required Intervention;
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