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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ADVANTA VXT VASCULAR GRAFT > OR = 6MM; PROSTHESIS VASCULAR GRAFT
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ATRIUM MEDICAL CORP. ADVANTA VXT VASCULAR GRAFT > OR = 6MM; PROSTHESIS VASCULAR GRAFT Back to Search Results
Model Number 21212
Device Problems Inadequacy of Device Shape and/or Size (1583); Unraveled Material (1664)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2014
Event Type  Injury  
Event Description
The doctor had to cut the graft to fit the right size.The graft kept unraveling, so he opened a new graft.
 
Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
 
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Brand Name
ADVANTA VXT VASCULAR GRAFT > OR = 6MM
Type of Device
PROSTHESIS VASCULAR GRAFT
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key3893953
MDR Text Key4649609
Report Number1219977-2014-00185
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992960
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model Number21212
Device Catalogue Number21212
Device Lot Number10917266
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
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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