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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ADVANTA VXT GRAFT
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ATRIUM MEDICAL CORP. ADVANTA VXT GRAFT Back to Search Results
Model Number 22979
Device Problem Torn Material (3024)
Patient Problem No Information (3190)
Event Date 03/10/2014
Event Type  Injury  
Event Description
Report stated that the physician noted that the graft was torn parallel to the helix when the slider sheath was removed following implantation of the graft.The helix was also torn/cut.After the torn portion of the graft was trimmed, non-damaged portion was anastomosed.
 
Manufacturer Narrative
We are in the process of performing the investigation and a follow-up report shall be submitted upon completion of the evaluation.
 
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Brand Name
ADVANTA VXT GRAFT
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
lori gosselin, sr, specialist
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3763692
MDR Text Key20784843
Report Number1219977-2014-00129
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K992960
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2017
Device Model Number22979
Device Catalogue Number22979
Device Lot Number10854389
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/20/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/11/2014
Initial Date FDA Received04/03/2014
Date Device Manufactured08/01/2012
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 Age80 YR
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