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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. V12 COVERED STENT; PROSTHESIS, VASCULAR GRAFT
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ATRIUM MEDICAL CORP. V12 COVERED STENT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Model Number 85365
Device Problem Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 02/04/2015
Event Type  Injury  
Event Description
Stent deployed in superior mesenteric artery (sma).Post stent deployment the balloon could not be removed through the sheath.The sheath and balloon had to be removed together.
 
Manufacturer Narrative
We are awaiting the return of the device for investigation and will submit the follow-up report once the evaluation is completed.
 
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Brand Name
V12 COVERED STENT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
lori gosselin, sr. complaints
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key4522886
MDR Text Key20070059
Report Number1219977-2015-00047
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model Number85365
Device Catalogue Number85365
Device Lot Number219073
Is the Reporter a Health Professional? No
Date Manufacturer Received02/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
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
GUIDE WIRE - .035 X260CM (COOK); INTRODUCER SHEATH - 7FR (TERUMO; BRANCHED LEVAR GRAFT (COOK)
Patient Outcome(s) Required Intervention;
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