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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 85337
Device Problems Detachment Of Device Component (1104); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2015
Event Type  Injury  
Event Description
Physician was performing an intervention for splenic artery aneurysm.While deploying the stent through a 7fr sheath in hepatic artery, the stent jumped due to torturous and curved anatomy and detached from the balloon.The stent had to be removed surgically.
 
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 Key4522898
MDR Text Key16863966
Report Number1219977-2015-00046
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/08/2015
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 Date06/30/2015
Device Model Number85337
Device Catalogue Number85337
Device Lot Number10841061
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2015
Initial Date FDA Received02/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE WIRE - AMPLATZ (BOSTON SCIENTIFIC); .035 X 300CM; INTRODUCER SHEATH - 7FR X 70CM (COOK)
Patient Outcome(s) Required Intervention;
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