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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT
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ATRIUM MEDICAL CORP. ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT Back to Search Results
Model Number 85337
Device Problems Break (1069); Deflation Problem (1149)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 04/02/2015
Event Type  Injury  
Event Description
The physician deployed a stent without a problem at the target.He had difficulty deflating the balloon.The physician pulled on the balloon which resulted in the balloon breaking off the catheter.The balloon was retrieved with a snare.Bleeding resolved with viabhan interna.
 
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
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Brand Name
ATRIUM ADVANTA V12 COVERED STENT
Type of Device
PTFE COVERED STENT
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
lynda mclaughlin
5 wentworth dr.
hudson, NH 03051
6038645470
MDR Report Key4729556
MDR Text Key5743054
Report Number1219977-2015-00126
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2018
Device Model Number85337
Device Catalogue Number85337
Device Lot Number221039
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2015
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 Age50 YR
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